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FDA 510(k)

ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT

K-Number: K971458 · 1997-09-02

ApplicantDiagnostic Specialties
Decision Date1997-09-02
Product CodeJIQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN 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 1997-09-02 under 510(k) number K971458. The device is classified under product code JIQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT?

ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT is a medical device that received FDA 510(k) clearance on 1997-09-02. The listed applicant is Diagnostic Specialties. The 510(k) number is K971458.

When did ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT receive FDA 510(k) clearance?

ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT received FDA 510(k) clearance on 1997-09-02, under 510(k) number K971458.

Who is the listed applicant for ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN 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 IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT?

The FDA product code for ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT is JIQ.

Related Clinical Trials

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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.

K941001ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITK930823PROTEIN-BOUND GLUCOSE ASSAYN KITK922032ENZIP URINARY MICROALBUMIN TESTK831180PREGNA-CERT, SLIDE PREGNANCY TESTK823109GENERIC PREGNANCY TESTK813608POTASSIUM REAGENT SET

View all 8 devices →

Related Devices (Code: JIQ)

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.

K013643AUSAM TOTAL ALBUMIN ASSAYAusam Biotecthnologies, Inc.K991800HEMOCHEK URINE COLLECTION KITOsborn Group, Inc.K965035IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENTBeckman Instruments, Inc.K944664WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATORWako Chemicals USA, Inc.K936202URINARY ALBUMIN TEST PACKDupont Medical ProductsK935662SYNERMED IR 500 CHEMISTRY ANALYZERSynermed, 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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