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FDA 510(k)

GEMCAL ENI REFERENCE SERUM

K-Number: K844344 · 1985-01-03

ApplicantBiocell Laboratories, Inc.
Decision Date1985-01-03
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEMCAL ENI REFERENCE SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Biocell Laboratories, Inc.. It received FDA 510(k) clearance on 1985-01-03 under 510(k) number K844344. 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 GEMCAL ENI REFERENCE SERUM?

GEMCAL ENI REFERENCE SERUM is a medical device that received FDA 510(k) clearance on 1985-01-03. The listed applicant is Biocell Laboratories, Inc.. The 510(k) number is K844344.

When did GEMCAL ENI REFERENCE SERUM receive FDA 510(k) clearance?

GEMCAL ENI REFERENCE SERUM received FDA 510(k) clearance on 1985-01-03, under 510(k) number K844344.

Who is the listed applicant for GEMCAL ENI REFERENCE SERUM?

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

What is the FDA product code for GEMCAL ENI REFERENCE SERUM?

The FDA product code for GEMCAL ENI REFERENCE SERUM is JIX.

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Other records listing Biocell Laboratories, Inc. as applicant

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Related Devices (Code: JIX)

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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