FDA 510(k)

AST OR SGOT

K-Number: K971344 · 1997-04-21

ApplicantCarolina Liquid Chemistries Corp.

Decision Date1997-04-21

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AST OR SGOT is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Liquid Chemistries Corp.. It received FDA 510(k) clearance on 1997-04-21 under 510(k) number K971344. 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 OR SGOT?

AST OR SGOT is a medical device that received FDA 510(k) clearance on 1997-04-21. The listed applicant is Carolina Liquid Chemistries Corp.. The 510(k) number is K971344.

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

AST OR SGOT received FDA 510(k) clearance on 1997-04-21, under 510(k) number K971344.

Who is the listed applicant for AST OR SGOT?

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

What is the FDA product code for AST OR SGOT?

The FDA product code for AST OR SGOT is CIT.

Other records listing Carolina Liquid Chemistries Corp. 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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System K972073TOTAL BILIRUBIN REAGENT K971907CALCIUM REAGENT K971324TRIGLYCERIDES, TG, OR TRIG K971967BUN K971908CREA OR CREATININE

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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.