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FDA 510(k)

HPC TM (HEPARINIZED PLASMA CONTROL)

K-Number: K770188 · 1977-02-18

ApplicantBio/Data Corp.
Decision Date1977-02-18
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HPC TM (HEPARINIZED PLASMA CONTROL) 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 1977-02-18 under 510(k) number K770188. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HPC TM (HEPARINIZED PLASMA CONTROL)?

HPC TM (HEPARINIZED PLASMA CONTROL) is a medical device that received FDA 510(k) clearance on 1977-02-18. The listed applicant is Bio/Data Corp.. The 510(k) number is K770188.

When did HPC TM (HEPARINIZED PLASMA CONTROL) receive FDA 510(k) clearance?

HPC TM (HEPARINIZED PLASMA CONTROL) received FDA 510(k) clearance on 1977-02-18, under 510(k) number K770188.

Who is the listed applicant for HPC TM (HEPARINIZED PLASMA CONTROL)?

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 HPC TM (HEPARINIZED PLASMA CONTROL)?

The FDA product code for HPC TM (HEPARINIZED PLASMA CONTROL) is GGC.

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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: GGC)

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.

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory COK100103SPECIALTY ASSAYED CONTROL-2Helena LaboratoriesK062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision BiologicK023312CONTROL PLASMA PDade Behring, 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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