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FDA 510(k)

AST(SGOT) IN VITRO DIAG. REAGENT SET

K-Number: K813405 · 1981-12-22

ApplicantPointe Scientific, Inc.,
Decision Date1981-12-22
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AST(SGOT) IN VITRO DIAG. REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 1981-12-22 under 510(k) number K813405. 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) IN VITRO DIAG. REAGENT SET?

AST(SGOT) IN VITRO DIAG. REAGENT SET is a medical device that received FDA 510(k) clearance on 1981-12-22. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K813405.

When did AST(SGOT) IN VITRO DIAG. REAGENT SET receive FDA 510(k) clearance?

AST(SGOT) IN VITRO DIAG. REAGENT SET received FDA 510(k) clearance on 1981-12-22, under 510(k) number K813405.

Who is the listed applicant for AST(SGOT) IN VITRO DIAG. REAGENT SET?

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

What is the FDA product code for AST(SGOT) IN VITRO DIAG. REAGENT SET?

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

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Other records listing Pointe 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.

K070757MICROPROTEIN REAGENT SETK062118POINTE 360K070251CARBON DIOXIDE LIQUID STABLE REAGENTK070207MULTI-ANALYTE CHEMISTRY CALIBRATORK070504AMMONIA/ALCOHOL CONTROL SETK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

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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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