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FDA 510(k)

COLORIMETRIC DETERMINATION (SGOT/SGPT)

K-Number: K760010 · 1976-07-26

ApplicantThe Dow Chemical Co.
Decision Date1976-07-26
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COLORIMETRIC DETERMINATION (SGOT/SGPT) is the device name listed in this FDA 510(k) record. The listed applicant is The Dow Chemical Co.. It received FDA 510(k) clearance on 1976-07-26 under 510(k) number K760010. 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 COLORIMETRIC DETERMINATION (SGOT/SGPT)?

COLORIMETRIC DETERMINATION (SGOT/SGPT) is a medical device that received FDA 510(k) clearance on 1976-07-26. The listed applicant is The Dow Chemical Co.. The 510(k) number is K760010.

When did COLORIMETRIC DETERMINATION (SGOT/SGPT) receive FDA 510(k) clearance?

COLORIMETRIC DETERMINATION (SGOT/SGPT) received FDA 510(k) clearance on 1976-07-26, under 510(k) number K760010.

Who is the listed applicant for COLORIMETRIC DETERMINATION (SGOT/SGPT)?

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

What is the FDA product code for COLORIMETRIC DETERMINATION (SGOT/SGPT)?

The FDA product code for COLORIMETRIC DETERMINATION (SGOT/SGPT) is CIT.

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Other records listing The Dow Chemical Co. 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.

K823474ENZYMATIC GLUCOSE DETERMINATIONK822154UREA NITROGEN (ENZYMATIC) DETERMINATIONK821536DOWFLOW ALT-UV DETERMINATIONK821315DOWFLOW ENZYMATIC TRIGLYCERIDES DETERMK820675BILIRUBIN(TOTAL) DETERMINATION CTMSK820714DOW BILIRUBIN(DIRECT) DETERMINATION

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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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