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FDA 510(k)

CPK COLOR TEST KIT

K-Number: K771849 · 1977-11-03

ApplicantMallinckrodt Critical Care
Decision Date1977-11-03
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CPK COLOR TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1977-11-03 under 510(k) number K771849. 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 CPK COLOR TEST KIT?

CPK COLOR TEST KIT is a medical device that received FDA 510(k) clearance on 1977-11-03. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K771849.

When did CPK COLOR TEST KIT receive FDA 510(k) clearance?

CPK COLOR TEST KIT received FDA 510(k) clearance on 1977-11-03, under 510(k) number K771849.

Who is the listed applicant for CPK COLOR TEST KIT?

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

What is the FDA product code for CPK COLOR TEST KIT?

The FDA product code for CPK COLOR TEST KIT is CGS.

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Other records listing Mallinckrodt Critical Care 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.

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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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