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FDA 510(k)

AST (GOT) - ASPARTATE AMINOTRANSFERASE

K-Number: K923505 · 1992-11-16

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

Device Summary

AST (GOT) - ASPARTATE 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 K923505. The device is classified under product code CIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AST (GOT) - ASPARTATE AMINOTRANSFERASE?

AST (GOT) - ASPARTATE 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 K923505.

When did AST (GOT) - ASPARTATE AMINOTRANSFERASE receive FDA 510(k) clearance?

AST (GOT) - ASPARTATE AMINOTRANSFERASE received FDA 510(k) clearance on 1992-11-16, under 510(k) number K923505.

Who is the listed applicant for AST (GOT) - ASPARTATE 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 AST (GOT) - ASPARTATE AMINOTRANSFERASE?

The FDA product code for AST (GOT) - ASPARTATE AMINOTRANSFERASE is CIT.

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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: CIT)

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.

K093883AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-Seppim S.A.S.K080485ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FSDiasys Diagnostics Systems GmbHK071525ACTIVATED ASPARTATE AMINOTRANSFERASEAbbott LaboratoriesK071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROLThermofisher Scientific OYK071211COBAS C 111 ANALYZERRoche DiagnosticsK060318HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx

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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