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FDA 510(k)

HI CHEM CALIBRATOR A+

K-Number: K895135 · 1989-10-23

ApplicantHichem Diagnostics
Decision Date1989-10-23
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI CHEM CALIBRATOR A+ is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1989-10-23 under 510(k) number K895135. 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 HI CHEM CALIBRATOR A+?

HI CHEM CALIBRATOR A+ is a medical device that received FDA 510(k) clearance on 1989-10-23. The listed applicant is Hichem Diagnostics. The 510(k) number is K895135.

When did HI CHEM CALIBRATOR A+ receive FDA 510(k) clearance?

HI CHEM CALIBRATOR A+ received FDA 510(k) clearance on 1989-10-23, under 510(k) number K895135.

Who is the listed applicant for HI CHEM CALIBRATOR A+?

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

What is the FDA product code for HI CHEM CALIBRATOR A+?

The FDA product code for HI CHEM CALIBRATOR A+ is JIX.

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Other records listing Hichem Diagnostics 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.

K981794HICHEM CALCIUM REAGENT KITK963383HICHEM ALP/AMP REAGENT KITK953860HICHEM ISE DILUENT KIT 70008K953862HICHEM ISEKCI SOLUTION KIT 70010K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953863HICHEM ISE STANDARDS KIT 70011

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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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