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FDA 510(k)

DURAZYME GOT/AST

K-Number: K800116 · 1980-02-13

ApplicantAmerican Monitor Corp.
Decision Date1980-02-13
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DURAZYME GOT/AST 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 1980-02-13 under 510(k) number K800116. 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 DURAZYME GOT/AST?

DURAZYME GOT/AST is a medical device that received FDA 510(k) clearance on 1980-02-13. The listed applicant is American Monitor Corp.. The 510(k) number is K800116.

When did DURAZYME GOT/AST receive FDA 510(k) clearance?

DURAZYME GOT/AST received FDA 510(k) clearance on 1980-02-13, under 510(k) number K800116.

Who is the listed applicant for DURAZYME GOT/AST?

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 DURAZYME GOT/AST?

The FDA product code for DURAZYME GOT/AST 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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