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FDA 510(k)

THROMBOPLASTIN.C

K-Number: K874592 · 1988-02-04

ApplicantBaxter Healthcare Corp
Decision Date1988-02-04
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBOPLASTIN.C 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 1988-02-04 under 510(k) number K874592. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBOPLASTIN.C?

THROMBOPLASTIN.C is a medical device that received FDA 510(k) clearance on 1988-02-04. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K874592.

When did THROMBOPLASTIN.C receive FDA 510(k) clearance?

THROMBOPLASTIN.C received FDA 510(k) clearance on 1988-02-04, under 510(k) number K874592.

Who is the listed applicant for THROMBOPLASTIN.C?

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 THROMBOPLASTIN.C?

The FDA product code for THROMBOPLASTIN.C is GJS.

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Related Devices (Code: GJS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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