FDA 510(k)

STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III

K-Number: K874757 · 1988-02-02

Decision Date1988-02-02

Product CodeDIF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III 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 1988-02-02 under 510(k) number K874757. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III?

STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III is a medical device that received FDA 510(k) clearance on 1988-02-02. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K874757.

When did STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III receive FDA 510(k) clearance?

STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III received FDA 510(k) clearance on 1988-02-02, under 510(k) number K874757.

Who is the listed applicant for STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III?

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) IMMUNOASSAY CONTROLS LEVELS I, II, III?

The FDA product code for STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III is DIF.

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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.