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FDA 510(k)

MICROSAMPLE COAGULATION ANALYSER MODEL 110P

K-Number: K854546 · 1986-01-07

ApplicantBio/Data Corp.
Decision Date1986-01-07
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MICROSAMPLE COAGULATION ANALYSER MODEL 110P 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 1986-01-07 under 510(k) number K854546. 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 MICROSAMPLE COAGULATION ANALYSER MODEL 110P?

MICROSAMPLE COAGULATION ANALYSER MODEL 110P is a medical device that received FDA 510(k) clearance on 1986-01-07. The listed applicant is Bio/Data Corp.. The 510(k) number is K854546.

When did MICROSAMPLE COAGULATION ANALYSER MODEL 110P receive FDA 510(k) clearance?

MICROSAMPLE COAGULATION ANALYSER MODEL 110P received FDA 510(k) clearance on 1986-01-07, under 510(k) number K854546.

Who is the listed applicant for MICROSAMPLE COAGULATION ANALYSER MODEL 110P?

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 MICROSAMPLE COAGULATION ANALYSER MODEL 110P?

The FDA product code for MICROSAMPLE COAGULATION ANALYSER MODEL 110P 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 ANALYZERK893650PLATELET AGGREGATION PROFILER MODEL PAP-4CK881150KINETIC FIBRINOGEN ASSAYK873382PLATELET EXTRACT REAGENTK860751VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA

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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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