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FDA 510(k)

ALT (GPT) - ALANINE AMINOTRANSFERASE

K-Number: K923510 · 1992-11-16

ApplicantRandox Laboratories, Ltd.
Decision Date1992-11-16
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALT (GPT) - ALANINE AMINOTRANSFERASE is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 1992-11-16 under 510(k) number K923510. 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 ALT (GPT) - ALANINE AMINOTRANSFERASE?

ALT (GPT) - ALANINE AMINOTRANSFERASE is a medical device that received FDA 510(k) clearance on 1992-11-16. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K923510.

When did ALT (GPT) - ALANINE AMINOTRANSFERASE receive FDA 510(k) clearance?

ALT (GPT) - ALANINE AMINOTRANSFERASE received FDA 510(k) clearance on 1992-11-16, under 510(k) number K923510.

Who is the listed applicant for ALT (GPT) - ALANINE AMINOTRANSFERASE?

The FDA 510(k) record lists Randox Laboratories, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALT (GPT) - ALANINE AMINOTRANSFERASE?

The FDA product code for ALT (GPT) - ALANINE AMINOTRANSFERASE is CKA.

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Other records listing Randox Laboratories, Ltd. 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.

K230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)K152085Liquid CO2-2 (LCO2-2)K153435Direct HDL Cholesterol (HDL)K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

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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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