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FDA 510(k)

DADE RECOMBOPLASTIN S

K-Number: K921326 · 1992-07-27

ApplicantBaxter Diagnostics, Inc.
Decision Date1992-07-27
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE RECOMBOPLASTIN S is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-07-27 under 510(k) number K921326. 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 DADE RECOMBOPLASTIN S?

DADE RECOMBOPLASTIN S is a medical device that received FDA 510(k) clearance on 1992-07-27. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K921326.

When did DADE RECOMBOPLASTIN S receive FDA 510(k) clearance?

DADE RECOMBOPLASTIN S received FDA 510(k) clearance on 1992-07-27, under 510(k) number K921326.

Who is the listed applicant for DADE RECOMBOPLASTIN S?

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

What is the FDA product code for DADE RECOMBOPLASTIN S?

The FDA product code for DADE RECOMBOPLASTIN S is GJS.

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Other records listing Baxter Diagnostics, Inc. as applicant

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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Related Devices (Code: GJS)

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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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