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FDA 510(k)

AST (SGOT)

K-Number: K013698 · 2001-12-21

ApplicantJas Diagnostics, Inc.
Decision Date2001-12-21
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 Jas Diagnostics, Inc.. It received FDA 510(k) clearance on 2001-12-21 under 510(k) number K013698. 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 2001-12-21. The listed applicant is Jas Diagnostics, Inc.. The 510(k) number is K013698.

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

AST (SGOT) received FDA 510(k) clearance on 2001-12-21, under 510(k) number K013698.

Who is the listed applicant for AST (SGOT)?

The FDA 510(k) record lists Jas Diagnostics, 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 Jas Diagnostics, 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.

K080623CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NAK080618DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUIDK022519LDL CHOLESTEROL (AUTOMATED)K021671JAS HDL CHOLESTEROL (AUTOMATED) REAGENTK020454CHEMISTRY CALIBRATORK020282JAS AMYLASE LIQUID REAGENT

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Related Devices (Code: CIT)

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.

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 GmbHK071525ACTIVATED ASPARTATE AMINOTRANSFERASEAbbott LaboratoriesK071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROLThermofisher Scientific OYK071211COBAS C 111 ANALYZERRoche DiagnosticsK060318HEPATIC 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.

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