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FDA 510(k)

CK-MB ASSAY, CATALOGUE NUMBER 317-10

K-Number: K942773 · 1994-08-24

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1994-08-24
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK-MB ASSAY, CATALOGUE NUMBER 317-10 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1994-08-24 under 510(k) number K942773. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CK-MB ASSAY, CATALOGUE NUMBER 317-10?

CK-MB ASSAY, CATALOGUE NUMBER 317-10 is a medical device that received FDA 510(k) clearance on 1994-08-24. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K942773.

When did CK-MB ASSAY, CATALOGUE NUMBER 317-10 receive FDA 510(k) clearance?

CK-MB ASSAY, CATALOGUE NUMBER 317-10 received FDA 510(k) clearance on 1994-08-24, under 510(k) number K942773.

Who is the listed applicant for CK-MB ASSAY, CATALOGUE NUMBER 317-10?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CK-MB ASSAY, CATALOGUE NUMBER 317-10?

The FDA product code for CK-MB ASSAY, CATALOGUE NUMBER 317-10 is CGS.

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Other records listing Diagnostic Chemicals , Ltd. as applicant

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Related Devices (Code: CGS)

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K191296Pointe Scientific Creatinine Kinase (CK) Reagent SetMedtest DXK182702SEKURE Creatine Kinase AssaySekisui Diagnostics P.E.I., Inc.K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATORRandox Laboratories, Ltd.K112416CPK REAGENTVital Diagnostics (Manufacturing) PtyltdK083465DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics

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.

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