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FDA 510(k)

CENTRIFICHEM COMB. SERUM-BASED CALIB.

K-Number: K802741 · 1980-12-10

ApplicantUnion Carbide Corp.
Decision Date1980-12-10
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRIFICHEM COMB. SERUM-BASED CALIB. is the device name listed in this FDA 510(k) record. The listed applicant is Union Carbide Corp.. It received FDA 510(k) clearance on 1980-12-10 under 510(k) number K802741. 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 CENTRIFICHEM COMB. SERUM-BASED CALIB.?

CENTRIFICHEM COMB. SERUM-BASED CALIB. is a medical device that received FDA 510(k) clearance on 1980-12-10. The listed applicant is Union Carbide Corp.. The 510(k) number is K802741.

When did CENTRIFICHEM COMB. SERUM-BASED CALIB. receive FDA 510(k) clearance?

CENTRIFICHEM COMB. SERUM-BASED CALIB. received FDA 510(k) clearance on 1980-12-10, under 510(k) number K802741.

Who is the listed applicant for CENTRIFICHEM COMB. SERUM-BASED CALIB.?

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

What is the FDA product code for CENTRIFICHEM COMB. SERUM-BASED CALIB.?

The FDA product code for CENTRIFICHEM COMB. SERUM-BASED CALIB. is JIX.

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Other records listing Union Carbide Corp. as applicant

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K830337MARK III OXYGEN WALKER SYS-LOW PRESSK820836MARK III OXYGEN WALKER SYSTEMK820535LASER GAS MIXTURESK812536LINDE MARK IIK810732LINDE MARK II OXYGEN RESERV. TYPE OR-4K810596CENTRIFI CHEM SYSTEM 400 ANALYZER

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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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