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FDA 510(k)

TEST, C-REATIVE PROTEIN, LATEX SLIDE

K-Number: K760035 · 1976-08-03

ApplicantGamma Biologicals, Inc.
Decision Date1976-08-03
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TEST, C-REATIVE PROTEIN, LATEX SLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Biologicals, Inc.. It received FDA 510(k) clearance on 1976-08-03 under 510(k) number K760035. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEST, C-REATIVE PROTEIN, LATEX SLIDE?

TEST, C-REATIVE PROTEIN, LATEX SLIDE is a medical device that received FDA 510(k) clearance on 1976-08-03. The listed applicant is Gamma Biologicals, Inc.. The 510(k) number is K760035.

When did TEST, C-REATIVE PROTEIN, LATEX SLIDE receive FDA 510(k) clearance?

TEST, C-REATIVE PROTEIN, LATEX SLIDE received FDA 510(k) clearance on 1976-08-03, under 510(k) number K760035.

Who is the listed applicant for TEST, C-REATIVE PROTEIN, LATEX SLIDE?

The FDA 510(k) record lists Gamma Biologicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEST, C-REATIVE PROTEIN, LATEX SLIDE?

The FDA product code for TEST, C-REATIVE PROTEIN, LATEX SLIDE is DCK.

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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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