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FDA 510(k)

SGOT-UV REAGENT SET

K-Number: K821208 · 1982-07-20

ApplicantOmega Medical Electronics
Decision Date1982-07-20
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SGOT-UV REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Electronics. It received FDA 510(k) clearance on 1982-07-20 under 510(k) number K821208. 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 SGOT-UV REAGENT SET?

SGOT-UV REAGENT SET is a medical device that received FDA 510(k) clearance on 1982-07-20. The listed applicant is Omega Medical Electronics. The 510(k) number is K821208.

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

SGOT-UV REAGENT SET received FDA 510(k) clearance on 1982-07-20, under 510(k) number K821208.

Who is the listed applicant for SGOT-UV REAGENT SET?

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

What is the FDA product code for SGOT-UV REAGENT SET?

The FDA product code for SGOT-UV REAGENT SET is CIT.

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Other records listing Omega Medical Electronics 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.

K823691PHOSPHORUS REAGENT SETK821212UREA NITROGEN REAGENT SETK821206SGPT-UV REAGENT SETK821204GLUCOSE(ENZYMATIC) REAGENT SETK821201LDH-UV REAGENT SETK821205TRIGLYCERIDE REAGENT SET

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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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