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FDA 510(k)

PLATELET EXTRACT REAGENT

K-Number: K873382 · 1987-11-20

ApplicantBio/Data Corp.
Decision Date1987-11-20
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET EXTRACT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Bio/Data Corp.. It received FDA 510(k) clearance on 1987-11-20 under 510(k) number K873382. The device is classified under product code GGW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELET EXTRACT REAGENT?

PLATELET EXTRACT REAGENT is a medical device that received FDA 510(k) clearance on 1987-11-20. The listed applicant is Bio/Data Corp.. The 510(k) number is K873382.

When did PLATELET EXTRACT REAGENT receive FDA 510(k) clearance?

PLATELET EXTRACT REAGENT received FDA 510(k) clearance on 1987-11-20, under 510(k) number K873382.

Who is the listed applicant for PLATELET EXTRACT REAGENT?

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

What is the FDA product code for PLATELET EXTRACT REAGENT?

The FDA product code for PLATELET EXTRACT REAGENT is GGW.

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Other records listing Bio/Data Corp. 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.

K001891MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-CK943153MICROSAMPLE COAGULATION ANALYZERK893650PLATELET AGGREGATION PROFILER MODEL PAP-4CK881150KINETIC FIBRINOGEN ASSAYK860751VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMAK860342MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP

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Related Devices (Code: GGW)

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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