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FDA 510(k)

COAGULATION CONTROL PLASMA LEVEL 1/2/3

K-Number: K841461 · 1984-05-02

ApplicantDiatech, Inc.
Decision Date1984-05-02
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAGULATION CONTROL PLASMA LEVEL 1/2/3 is the device name listed in this FDA 510(k) record. The listed applicant is Diatech, Inc.. It received FDA 510(k) clearance on 1984-05-02 under 510(k) number K841461. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAGULATION CONTROL PLASMA LEVEL 1/2/3?

COAGULATION CONTROL PLASMA LEVEL 1/2/3 is a medical device that received FDA 510(k) clearance on 1984-05-02. The listed applicant is Diatech, Inc.. The 510(k) number is K841461.

When did COAGULATION CONTROL PLASMA LEVEL 1/2/3 receive FDA 510(k) clearance?

COAGULATION CONTROL PLASMA LEVEL 1/2/3 received FDA 510(k) clearance on 1984-05-02, under 510(k) number K841461.

Who is the listed applicant for COAGULATION CONTROL PLASMA LEVEL 1/2/3?

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

What is the FDA product code for COAGULATION CONTROL PLASMA LEVEL 1/2/3?

The FDA product code for COAGULATION CONTROL PLASMA LEVEL 1/2/3 is GGP.

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Other records listing Diatech, Inc. 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.

K881685FIBRINOGENTEST-OK854938COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.K854089DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENTK854090DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENTK842286DIA T1, T2 & T3K841366DIA FIBRIN

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Related Devices (Code: GGP)

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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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