FDA 510(k)

ASPARTATE AMINOTRANFERASE (AST)

K-Number: K896000 · 1990-01-11

Decision Date1990-01-11

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ASPARTATE AMINOTRANFERASE (AST) is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1990-01-11 under 510(k) number K896000. 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 ASPARTATE AMINOTRANFERASE (AST)?

ASPARTATE AMINOTRANFERASE (AST) is a medical device that received FDA 510(k) clearance on 1990-01-11. The listed applicant is American Monitor Corp.. The 510(k) number is K896000.

When did ASPARTATE AMINOTRANFERASE (AST) receive FDA 510(k) clearance?

ASPARTATE AMINOTRANFERASE (AST) received FDA 510(k) clearance on 1990-01-11, under 510(k) number K896000.

Who is the listed applicant for ASPARTATE AMINOTRANFERASE (AST)?

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

What is the FDA product code for ASPARTATE AMINOTRANFERASE (AST)?

The FDA product code for ASPARTATE AMINOTRANFERASE (AST) is CIT.

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Other records listing American Monitor Corp. as applicant

K895999PHOSPHORUS K896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZER K893137EXCEL (TM) CHEMISTRY ANALYZER K892331ENZYMATIC UREA NITROGEN REAGENT SET K893479CHOLESTEROL REAGENT SET

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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.