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FDA 510(k)

SYPHILIS BIO-ENZABEAD KIT

K-Number: K820934 · 1982-06-10

ApplicantBiometics Laboratory Products
Decision Date1982-06-10
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SYPHILIS BIO-ENZABEAD KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biometics Laboratory Products. It received FDA 510(k) clearance on 1982-06-10 under 510(k) number K820934. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYPHILIS BIO-ENZABEAD KIT?

SYPHILIS BIO-ENZABEAD KIT is a medical device that received FDA 510(k) clearance on 1982-06-10. The listed applicant is Biometics Laboratory Products. The 510(k) number is K820934.

When did SYPHILIS BIO-ENZABEAD KIT receive FDA 510(k) clearance?

SYPHILIS BIO-ENZABEAD KIT received FDA 510(k) clearance on 1982-06-10, under 510(k) number K820934.

Who is the listed applicant for SYPHILIS BIO-ENZABEAD KIT?

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

What is the FDA product code for SYPHILIS BIO-ENZABEAD KIT?

The FDA product code for SYPHILIS BIO-ENZABEAD KIT is LIP.

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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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