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FDA 510(k)

THROMBOKINETIC FIBRINOGEN ASSAY

K-Number: K792563 · 1980-01-11

ApplicantBio/Data Corp.
Decision Date1980-01-11
Product CodeKQJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBOKINETIC FIBRINOGEN ASSAY 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 1980-01-11 under 510(k) number K792563. The device is classified under product code KQJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBOKINETIC FIBRINOGEN ASSAY?

THROMBOKINETIC FIBRINOGEN ASSAY is a medical device that received FDA 510(k) clearance on 1980-01-11. The listed applicant is Bio/Data Corp.. The 510(k) number is K792563.

When did THROMBOKINETIC FIBRINOGEN ASSAY receive FDA 510(k) clearance?

THROMBOKINETIC FIBRINOGEN ASSAY received FDA 510(k) clearance on 1980-01-11, under 510(k) number K792563.

Who is the listed applicant for THROMBOKINETIC FIBRINOGEN ASSAY?

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 THROMBOKINETIC FIBRINOGEN ASSAY?

The FDA product code for THROMBOKINETIC FIBRINOGEN ASSAY is KQJ.

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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: KQJ)

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.

K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLInstrumentation Laboratory (IL) Co.K073367HEMOSIL FIBRINOGEN-CInstrumentation Laboratory COK050928DADE THROMBIN REAGENTDade Behring, Inc.K971858SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)Sigma Diagnostics, Inc.K970189FIF TMPanbio, Inc.K965113N-ASSAY TIA FIBRINOGEN TEST KITCrestat Diagnostics, Inc.

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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