FDA 510(k)

MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT

K-Number: K862832 · 1986-08-12

ApplicantDiagnostic Chemicals, Ltd. (Usa)

Decision Date1986-08-12

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1986-08-12 under 510(k) number K862832. 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 MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT?

MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT is a medical device that received FDA 510(k) clearance on 1986-08-12. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K862832.

When did MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT receive FDA 510(k) clearance?

MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT received FDA 510(k) clearance on 1986-08-12, under 510(k) number K862832.

Who is the listed applicant for MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT?

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

What is the FDA product code for MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT?

The FDA product code for MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT is CIT.

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Related Devices (Code: CIT)

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 GmbH K071525ACTIVATED ASPARTATE AMINOTRANSFERASEAbbott Laboratories K071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROLThermofisher Scientific OY K071211COBAS C 111 ANALYZERRoche Diagnostics K060318HEPATIC 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.