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FDA 510(k)

ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT

K-Number: K941001 · 1994-08-30

ApplicantDiagnostic Specialties
Decision Date1994-08-30
Product CodeGIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Specialties. It received FDA 510(k) clearance on 1994-08-30 under 510(k) number K941001. The device is classified under product code GIS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT?

ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT is a medical device that received FDA 510(k) clearance on 1994-08-30. The listed applicant is Diagnostic Specialties. The 510(k) number is K941001.

When did ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT receive FDA 510(k) clearance?

ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT received FDA 510(k) clearance on 1994-08-30, under 510(k) number K941001.

Who is the listed applicant for ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT?

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

What is the FDA product code for ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT?

The FDA product code for ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT is GIS.

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Other records listing Diagnostic Specialties 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.

K971458ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KITK930823PROTEIN-BOUND GLUCOSE ASSAYN KITK922032ENZIP URINARY MICROALBUMIN TESTK831180PREGNA-CERT, SLIDE PREGNANCY TESTK823109GENERIC PREGNANCY TESTK813608POTASSIUM REAGENT SET

View all 8 devices →

Related Devices (Code: GIS)

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.

K143470Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control SetDiazyme LaboratoriesK042919FIBROTEK FIBR2 Diagnostics, Inc.K993482K-ASSAY FIBRINOGENKamiya Biomedical Co.K963902QUANTITATIVE FIBRINOGEN ASSAYOrtho Diagnostic Systems, Inc.K925494BIOMERIEUX HEMOLAB FIBRINOMATBiomerieux Vitek, Inc.K923921IL TEST PT FIBRINOGEN HSInstrumentation Laboratory CO

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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