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FDA 510(k)

N-ASSAY TIA MICROALBUMIN CALIBRATOR SET

K-Number: K934143 · 1993-11-05

ApplicantCrestat Diagnostics, Inc.
Decision Date1993-11-05
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

N-ASSAY TIA MICROALBUMIN CALIBRATOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Crestat Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-11-05 under 510(k) number K934143. 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 N-ASSAY TIA MICROALBUMIN CALIBRATOR SET?

N-ASSAY TIA MICROALBUMIN CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 1993-11-05. The listed applicant is Crestat Diagnostics, Inc.. The 510(k) number is K934143.

When did N-ASSAY TIA MICROALBUMIN CALIBRATOR SET receive FDA 510(k) clearance?

N-ASSAY TIA MICROALBUMIN CALIBRATOR SET received FDA 510(k) clearance on 1993-11-05, under 510(k) number K934143.

Who is the listed applicant for N-ASSAY TIA MICROALBUMIN CALIBRATOR SET?

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

What is the FDA product code for N-ASSAY TIA MICROALBUMIN CALIBRATOR SET?

The FDA product code for N-ASSAY TIA MICROALBUMIN CALIBRATOR SET is JIX.

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Other records listing Crestat Diagnostics, 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.

K980883N-ASSAY GLU-ULK981276N-ASSAY L D-BILK981289N-ASSAY L T-BILK980900N-ASSAY CPK-LK980902N-ASSAY L AST/GOTK972257N-ASSAY TIA ANTITHROMBIN III TEST KIT

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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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