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FDA 510(k)

PLATELET AGGREGATION PROFILER MODEL PAP-4C

K-Number: K893650 · 1989-06-23

ApplicantBio/Data Corp.
Decision Date1989-06-23
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET AGGREGATION PROFILER MODEL PAP-4C 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 1989-06-23 under 510(k) number K893650. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELET AGGREGATION PROFILER MODEL PAP-4C?

PLATELET AGGREGATION PROFILER MODEL PAP-4C is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Bio/Data Corp.. The 510(k) number is K893650.

When did PLATELET AGGREGATION PROFILER MODEL PAP-4C receive FDA 510(k) clearance?

PLATELET AGGREGATION PROFILER MODEL PAP-4C received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893650.

Who is the listed applicant for PLATELET AGGREGATION PROFILER MODEL PAP-4C?

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 AGGREGATION PROFILER MODEL PAP-4C?

The FDA product code for PLATELET AGGREGATION PROFILER MODEL PAP-4C is JPA.

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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 ANALYZERK881150KINETIC FIBRINOGEN ASSAYK873382PLATELET EXTRACT REAGENTK860751VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMAK860342MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP

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Related Devices (Code: JPA)

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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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