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FDA 510(k)

ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)

K-Number: K895261 · 1989-10-06

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1989-10-06
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1989-10-06 under 510(k) number K895261. 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 ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)?

ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2) is a medical device that received FDA 510(k) clearance on 1989-10-06. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K895261.

When did ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2) receive FDA 510(k) clearance?

ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2) received FDA 510(k) clearance on 1989-10-06, under 510(k) number K895261.

Who is the listed applicant for ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)?

The FDA 510(k) record lists Medical Diagnostic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)?

The FDA product code for ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2) is GGC.

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Other records listing Medical Diagnostic Technologies, Inc. as applicant

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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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