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FDA 510(k)

STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020

K-Number: K932049 · 1993-11-16

ApplicantStanbio Laboratory
Decision Date1993-11-16
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1993-11-16 under 510(k) number K932049. 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 STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020?

STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 is a medical device that received FDA 510(k) clearance on 1993-11-16. The listed applicant is Stanbio Laboratory. The 510(k) number is K932049.

When did STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 receive FDA 510(k) clearance?

STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 received FDA 510(k) clearance on 1993-11-16, under 510(k) number K932049.

Who is the listed applicant for STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020?

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

What is the FDA product code for STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020?

The FDA product code for STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 is CIT.

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Other records listing Stanbio Laboratory 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.

K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK050283CREATININE LIQUICOLORK050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERK041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY

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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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