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FDA 510(k)

SYNERMED AST/GOT REAGENT KIT

K-Number: K915555 · 1992-01-27

ApplicantSynermed, Inc.
Decision Date1992-01-27
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNERMED AST/GOT REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Synermed, Inc.. It received FDA 510(k) clearance on 1992-01-27 under 510(k) number K915555. 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 SYNERMED AST/GOT REAGENT KIT?

SYNERMED AST/GOT REAGENT KIT is a medical device that received FDA 510(k) clearance on 1992-01-27. The listed applicant is Synermed, Inc.. The 510(k) number is K915555.

When did SYNERMED AST/GOT REAGENT KIT receive FDA 510(k) clearance?

SYNERMED AST/GOT REAGENT KIT received FDA 510(k) clearance on 1992-01-27, under 510(k) number K915555.

Who is the listed applicant for SYNERMED AST/GOT REAGENT KIT?

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

What is the FDA product code for SYNERMED AST/GOT REAGENT KIT?

The FDA product code for SYNERMED AST/GOT REAGENT KIT is CIT.

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Other records listing Synermed, Inc. 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.

K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITK972716SYNERMED TOTAL BILIRUBIN REAGENT KITK971491SYNERMED IR 200 CHEMISTRY ANALYZERK962479SYNERMED ISE REAGENTSK963939SYNERMED DIRECT BILIRUBIN REAGENT KITK960793SYNERMED ENZYMATIC CO2 REAGENT KIT

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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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