FDA 510(k)

QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA

K-Number: K853925 · 1985-12-02

Decision Date1985-12-02

Product CodeJHI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Nms Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1985-12-02 under 510(k) number K853925. 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 QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA?

QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA is a medical device that received FDA 510(k) clearance on 1985-12-02. The listed applicant is Nms Pharmaceuticals, Inc.. The 510(k) number is K853925.

When did QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA receive FDA 510(k) clearance?

QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA received FDA 510(k) clearance on 1985-12-02, under 510(k) number K853925.

Who is the listed applicant for QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA?

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

What is the FDA product code for QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA?

The FDA product code for QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA is JHI.

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Related Devices (Code: JHI)

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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.