FDA 510(k)

AST/SGOT

K-Number: K991663 · 1999-06-30

Decision Date1999-06-30

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AST/SGOT is the device name listed in this FDA 510(k) record. The listed applicant is A.P. Total Care, Inc.. It received FDA 510(k) clearance on 1999-06-30 under 510(k) number K991663. 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/SGOT?

AST/SGOT is a medical device that received FDA 510(k) clearance on 1999-06-30. The listed applicant is A.P. Total Care, Inc.. The 510(k) number is K991663.

When did AST/SGOT receive FDA 510(k) clearance?

AST/SGOT received FDA 510(k) clearance on 1999-06-30, under 510(k) number K991663.

Who is the listed applicant for AST/SGOT?

The FDA 510(k) record lists A.P. Total Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AST/SGOT?

The FDA product code for AST/SGOT is CIT.

Other records listing A.P. Total Care, Inc. 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.

K991246FRUCTOSAMINE, MODEL FR 106-01 K991761MAGNESIUM PRODUCT NO'S, 112-01, 112-02 K991762ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 K991664LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 K991665HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 K991867INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02

View all 18 devices →

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.