FDA 510(k)

STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY

K-Number: K913236 · 1991-08-16

Decision Date1991-08-16

Product CodeDHA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1991-08-16 under 510(k) number K913236. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY?

STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1991-08-16. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K913236.

When did STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1991-08-16, under 510(k) number K913236.

Who is the listed applicant for STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY?

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

What is the FDA product code for STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY?

The FDA product code for STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY is DHA.

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Related Devices (Code: DHA)

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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.