FDA 510(k)

AST/SGOT

K-Number: K965126 · 1997-01-17

Decision Date1997-01-17

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 Derma Media Lab., Inc.. It received FDA 510(k) clearance on 1997-01-17 under 510(k) number K965126. 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 1997-01-17. The listed applicant is Derma Media Lab., Inc.. The 510(k) number is K965126.

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

AST/SGOT received FDA 510(k) clearance on 1997-01-17, under 510(k) number K965126.

Who is the listed applicant for AST/SGOT?

The FDA 510(k) record lists Derma Media Lab., 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 Derma Media Lab., 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.

K971309UREA K970664GLUCOSE REAGENT K971072CHOLESTEROL REAGENT K971005TRIGLYCERIDES K970867URIC ACID REAGENT K964915MAGNESIUM

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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.