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FDA 510(k)

AST/SGOT LIQUID REAGENT - KINETIC METHOD

K-Number: K981650 · 1998-06-29

ApplicantTeco Diagnostics
Decision Date1998-06-29
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AST/SGOT LIQUID REAGENT - KINETIC METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 1998-06-29 under 510(k) number K981650. 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 LIQUID REAGENT - KINETIC METHOD?

AST/SGOT LIQUID REAGENT - KINETIC METHOD is a medical device that received FDA 510(k) clearance on 1998-06-29. The listed applicant is Teco Diagnostics. The 510(k) number is K981650.

When did AST/SGOT LIQUID REAGENT - KINETIC METHOD receive FDA 510(k) clearance?

AST/SGOT LIQUID REAGENT - KINETIC METHOD received FDA 510(k) clearance on 1998-06-29, under 510(k) number K981650.

Who is the listed applicant for AST/SGOT LIQUID REAGENT - KINETIC METHOD?

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

What is the FDA product code for AST/SGOT LIQUID REAGENT - KINETIC METHOD?

The FDA product code for AST/SGOT LIQUID REAGENT - KINETIC METHOD is CIT.

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Other records listing Teco Diagnostics 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.

K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERK072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440

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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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