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FDA 510(k)

URIC ACID (TPTZ) COLORINMETRIC

K-Number: K810088 · 1981-01-28

ApplicantBio-Analytics Laboratories, Inc.
Decision Date1981-01-28
Product CodeCDH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID (TPTZ) COLORINMETRIC is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Analytics Laboratories, Inc.. It received FDA 510(k) clearance on 1981-01-28 under 510(k) number K810088. The device is classified under product code CDH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URIC ACID (TPTZ) COLORINMETRIC?

URIC ACID (TPTZ) COLORINMETRIC is a medical device that received FDA 510(k) clearance on 1981-01-28. The listed applicant is Bio-Analytics Laboratories, Inc.. The 510(k) number is K810088.

When did URIC ACID (TPTZ) COLORINMETRIC receive FDA 510(k) clearance?

URIC ACID (TPTZ) COLORINMETRIC received FDA 510(k) clearance on 1981-01-28, under 510(k) number K810088.

Who is the listed applicant for URIC ACID (TPTZ) COLORINMETRIC?

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

What is the FDA product code for URIC ACID (TPTZ) COLORINMETRIC?

The FDA product code for URIC ACID (TPTZ) COLORINMETRIC is CDH.

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Other records listing Bio-Analytics Laboratories, 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.

K861638KINETIC ALKALINE PHOSPHATASE REAGENT KITK860245ENZYMATIC ALPHA-AMYLASE REAGENT KITK860213ALBUMIN REAGENT KITK851513ULTRA-VIOLET BUN REAGENT KITK851514ULTRA-VIOLET GLUCOSE REAGENTK850639ENZYMATIC ALPHA-AMYLASE REAGENT KIT

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Related Devices (Code: CDH)

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.

K850933URIC ACIDDilab, Inc.K841067URIC ACID REAGENT SETMedical Specialties, Inc.K821213URIC ACID REAGENT SETOmega Medical ElectronicsK813076PHOSPHOTUNGSTATE REDUCTION, URIC ACIDAmerican Monitor Corp.K800672SMAC REPLACEMENT REAGENTS/DETERM-URIC-ACDiagnostic Solutions, Inc.K800190STANBIO DIRECT URIC ACID TEST SET #0770Stanbio Laboratory

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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