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FDA 510(k)

BIOCEPT-G

K-Number: K760336 · 1976-11-12

ApplicantWampole Laboratories
Decision Date1976-11-12
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOCEPT-G is the device name listed in this FDA 510(k) record. The listed applicant is Wampole Laboratories. It received FDA 510(k) clearance on 1976-11-12 under 510(k) number K760336. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCEPT-G?

BIOCEPT-G is a medical device that received FDA 510(k) clearance on 1976-11-12. The listed applicant is Wampole Laboratories. The 510(k) number is K760336.

When did BIOCEPT-G receive FDA 510(k) clearance?

BIOCEPT-G received FDA 510(k) clearance on 1976-11-12, under 510(k) number K760336.

Who is the listed applicant for BIOCEPT-G?

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

What is the FDA product code for BIOCEPT-G?

The FDA product code for BIOCEPT-G is JHI.

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Official Source

View on FDA Database →

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

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