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FDA 510(k)

CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3

K-Number: K090283 · 2009-06-05

ApplicantGenchem, Inc.
Decision Date2009-06-05
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 is the device name listed in this FDA 510(k) record. The listed applicant is Genchem, Inc.. It received FDA 510(k) clearance on 2009-06-05 under 510(k) number K090283. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3?

CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 is a medical device that received FDA 510(k) clearance on 2009-06-05. The listed applicant is Genchem, Inc.. The 510(k) number is K090283.

When did CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 receive FDA 510(k) clearance?

CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 received FDA 510(k) clearance on 2009-06-05, under 510(k) number K090283.

Who is the listed applicant for CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3?

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

What is the FDA product code for CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3?

The FDA product code for CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 is JIX.

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Other records listing Genchem, 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.

K040975GENCHEM CO2 ACID REAGENTK040977GENCHEM ELECTROLYTE BUFFERK040972CALCIUM, AZO DYE REAGENTK040973BUN REAGENTK040976GENCHEM CREATININE REAGENTK040974GLUCOSE OXIDASE, GLUCOSE

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Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.

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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