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FDA 510(k)

OPTIMIZED UV-GPT REAGENT SET

K-Number: K822494 · 1982-09-21

ApplicantBiorent Diagnostic, Inc.
Decision Date1982-09-21
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPTIMIZED UV-GPT REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Biorent Diagnostic, Inc.. It received FDA 510(k) clearance on 1982-09-21 under 510(k) number K822494. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMIZED UV-GPT REAGENT SET?

OPTIMIZED UV-GPT REAGENT SET is a medical device that received FDA 510(k) clearance on 1982-09-21. The listed applicant is Biorent Diagnostic, Inc.. The 510(k) number is K822494.

When did OPTIMIZED UV-GPT REAGENT SET receive FDA 510(k) clearance?

OPTIMIZED UV-GPT REAGENT SET received FDA 510(k) clearance on 1982-09-21, under 510(k) number K822494.

Who is the listed applicant for OPTIMIZED UV-GPT REAGENT SET?

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

What is the FDA product code for OPTIMIZED UV-GPT REAGENT SET?

The FDA product code for OPTIMIZED UV-GPT REAGENT SET is CKA.

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Other records listing Biorent Diagnostic, 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.

K832747ALBUMIN REAGENT SETK823060HEMOGLOBIN REAGENTK823211CK-UV REAGENTK822493OPTIMIZED UV-GOT REAGENT SETK822492OPTIMIZED UV-LDH REAGENT SETK820768COLORIMETRIC LDH REAGENT SET

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Related Devices (Code: CKA)

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.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, 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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