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FDA 510(k)

CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323

K-Number: K932768 · 1993-10-18

ApplicantHelena Laboratories
Decision Date1993-10-18
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1993-10-18 under 510(k) number K932768. 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 CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323?

CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323 is a medical device that received FDA 510(k) clearance on 1993-10-18. The listed applicant is Helena Laboratories. The 510(k) number is K932768.

When did CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323 receive FDA 510(k) clearance?

CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323 received FDA 510(k) clearance on 1993-10-18, under 510(k) number K932768.

Who is the listed applicant for CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323?

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

What is the FDA product code for CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323?

The FDA product code for CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323 is JIX.

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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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