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FDA 510(k)

SGOT/AST REAGENT SYSTEM

K-Number: K780443 · 1978-04-24

ApplicantAmerican Monitor Corp.
Decision Date1978-04-24
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SGOT/AST REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1978-04-24 under 510(k) number K780443. 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/AST REAGENT SYSTEM?

SGOT/AST REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1978-04-24. The listed applicant is American Monitor Corp.. The 510(k) number is K780443.

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

SGOT/AST REAGENT SYSTEM received FDA 510(k) clearance on 1978-04-24, under 510(k) number K780443.

Who is the listed applicant for SGOT/AST REAGENT SYSTEM?

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

What is the FDA product code for SGOT/AST REAGENT SYSTEM?

The FDA product code for SGOT/AST REAGENT SYSTEM is CIT.

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Other records listing American Monitor Corp. 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.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN 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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