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FDA 510(k)

IL TEST CK-MB

K-Number: K952646 · 1995-08-04

ApplicantInstrumentation Laboratory CO
Decision Date1995-08-04
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IL TEST CK-MB is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1995-08-04 under 510(k) number K952646. 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 IL TEST CK-MB?

IL TEST CK-MB is a medical device that received FDA 510(k) clearance on 1995-08-04. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K952646.

When did IL TEST CK-MB receive FDA 510(k) clearance?

IL TEST CK-MB received FDA 510(k) clearance on 1995-08-04, under 510(k) number K952646.

Who is the listed applicant for IL TEST CK-MB?

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

What is the FDA product code for IL TEST CK-MB?

The FDA product code for IL TEST CK-MB is CGS.

Other records listing Instrumentation Laboratory CO as applicant

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Related Devices (Code: CGS)

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.

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

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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