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FDA 510(k)

AST (SGOT) REAGENT SET

K-Number: K880276 · 1988-03-03

ApplicantTech-Neal Scientific, Inc.
Decision Date1988-03-03
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AST (SGOT) REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Neal Scientific, Inc.. It received FDA 510(k) clearance on 1988-03-03 under 510(k) number K880276. 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) REAGENT SET?

AST (SGOT) REAGENT SET is a medical device that received FDA 510(k) clearance on 1988-03-03. The listed applicant is Tech-Neal Scientific, Inc.. The 510(k) number is K880276.

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

AST (SGOT) REAGENT SET received FDA 510(k) clearance on 1988-03-03, under 510(k) number K880276.

Who is the listed applicant for AST (SGOT) REAGENT SET?

The FDA 510(k) record lists Tech-Neal Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AST (SGOT) REAGENT SET?

The FDA product code for AST (SGOT) REAGENT SET is CIT.

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Other records listing Tech-Neal Scientific, 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.

K882256MAGNESIUM REAGENT SETK882459DIAZO, COLORIMETRIC BILIRUBINK881239GAMMA GLUTAMYL TRANSFERASE REAGENT SETK881241TOTAL BILIRUBIN REAGENTK881240CHLORIDE REAGENT SETK880237CHOLESTEROL

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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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