FDA 510(k)

PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION

K-Number: K910309 · 1991-03-29

Decision Date1991-03-29

Product CodeJIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K910309. 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 PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION?

PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K910309.

When did PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION receive FDA 510(k) clearance?

PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION received FDA 510(k) clearance on 1991-03-29, under 510(k) number K910309.

Who is the listed applicant for PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION?

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

What is the FDA product code for PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION?

The FDA product code for PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION is JIX.

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Related Devices (Code: JIX)

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 Diagnostics K130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroup K123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare Diagnostics K123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott Laboratories K122398RAPIDPOINT 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.