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FDA 510(k)

B12/FOLATE SING. TUBE DUAL RADIOASSAY KT

K-Number: K760946 · 1976-12-21

ApplicantSchwarz Mann
Decision Date1976-12-21
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

B12/FOLATE SING. TUBE DUAL RADIOASSAY KT is the device name listed in this FDA 510(k) record. The listed applicant is Schwarz Mann. It received FDA 510(k) clearance on 1976-12-21 under 510(k) number K760946. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B12/FOLATE SING. TUBE DUAL RADIOASSAY KT?

B12/FOLATE SING. TUBE DUAL RADIOASSAY KT is a medical device that received FDA 510(k) clearance on 1976-12-21. The listed applicant is Schwarz Mann. The 510(k) number is K760946.

When did B12/FOLATE SING. TUBE DUAL RADIOASSAY KT receive FDA 510(k) clearance?

B12/FOLATE SING. TUBE DUAL RADIOASSAY KT received FDA 510(k) clearance on 1976-12-21, under 510(k) number K760946.

Who is the listed applicant for B12/FOLATE SING. TUBE DUAL RADIOASSAY KT?

The FDA 510(k) record lists Schwarz Mann as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B12/FOLATE SING. TUBE DUAL RADIOASSAY KT?

The FDA product code for B12/FOLATE SING. TUBE DUAL RADIOASSAY KT is CDD.

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Related Devices (Code: CDD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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