FDA 510(k)

AST

K-Number: K983131 · 1998-09-28

Decision Date1998-09-28

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AST is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-09-28 under 510(k) number K983131. 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?

AST is a medical device that received FDA 510(k) clearance on 1998-09-28. The listed applicant is Abbott Laboratories. The 510(k) number is K983131.

When did AST receive FDA 510(k) clearance?

AST received FDA 510(k) clearance on 1998-09-28, under 510(k) number K983131.

Who is the listed applicant for AST?

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

What is the FDA product code for AST?

The FDA product code for AST is CIT.

Related PubMed Literature

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.