§866.5980. Spinal Muscular Atrophy newborn screening test system. — Inbound Citations
21 C.F.R. § 866.5980
Statutory Authority
Cited by 11 regulations in release Current.
Citations to §866.5980(b)(1)(i)
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(iii) Description of the device information required under paragraphs (b)(1)(i) through (iv) of this section.
Citations to §866.5980(b)(1)(ii)
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(iii) Description of the device information required under paragraphs (b)(1)(i) through (iv) of this section.
Citations to §866.5980(b)(1)(iii)
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(iii) Description of the device information required under paragraphs (b)(1)(i) through (iv) of this section.
Citations to §866.5980(b)(1)(iv)
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(iii) Description of the device information required under paragraphs (b)(1)(i) through (iv) of this section.
Citations to §866.5980(b)(1)(v)(A)
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(iv) A summary of the results of the studies required under paragraphs (b)(1)(v)(A) through (G) of this section.
Citations to §866.5980(b)(1)(v)(B)
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(iv) A summary of the results of the studies required under paragraphs (b)(1)(v)(A) through (G) of this section.
Citations to §866.5980(b)(1)(v)(C)
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(iv) A summary of the results of the studies required under paragraphs (b)(1)(v)(A) through (G) of this section.
Citations to §866.5980(b)(1)(v)(D)
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(iv) A summary of the results of the studies required under paragraphs (b)(1)(v)(A) through (G) of this section.
Citations to §866.5980(b)(1)(v)(E)
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(iv) A summary of the results of the studies required under paragraphs (b)(1)(v)(A) through (G) of this section.
Citations to §866.5980(b)(1)(v)(F)
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(iv) A summary of the results of the studies required under paragraphs (b)(1)(v)(A) through (G) of this section.
Citations to §866.5980(b)(1)(v)(G)
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(iv) A summary of the results of the studies required under paragraphs (b)(1)(v)(A) through (G) of this section.