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FDA 510(k)

DIA REPTIN

K-Number: K841365 · 1984-06-01

ApplicantDiatech, Inc.
Decision Date1984-06-01
Product CodeGIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIA REPTIN is the device name listed in this FDA 510(k) record. The listed applicant is Diatech, Inc.. It received FDA 510(k) clearance on 1984-06-01 under 510(k) number K841365. The device is classified under product code GIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIA REPTIN?

DIA REPTIN is a medical device that received FDA 510(k) clearance on 1984-06-01. The listed applicant is Diatech, Inc.. The 510(k) number is K841365.

When did DIA REPTIN receive FDA 510(k) clearance?

DIA REPTIN received FDA 510(k) clearance on 1984-06-01, under 510(k) number K841365.

Who is the listed applicant for DIA REPTIN?

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 DIA REPTIN?

The FDA product code for DIA REPTIN is GIR.

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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 & T3K841462HEPARIN COAGULATION CONTROL PLASMA 1-

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Related Devices (Code: GIR)

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.

K110031HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRMInstrumentation Laboratory COK083878LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LAR2 Diagnostics, Inc.K061805STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRMDiagnostica Stago, Inc.K000528ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119Sigma Diagnostics, Inc.K000527ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094Sigma Diagnostics, Inc.K990580CRYOCHECK LA SURE, MODEL SUR25-10Precision Biologic

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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