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FDA 510(k)

ISOENZYME TEST CK-MB

K-Number: K850212 · 1985-02-07

ApplicantSclavo, Inc.
Decision Date1985-02-07
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISOENZYME TEST CK-MB is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1985-02-07 under 510(k) number K850212. 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 ISOENZYME TEST CK-MB?

ISOENZYME TEST CK-MB is a medical device that received FDA 510(k) clearance on 1985-02-07. The listed applicant is Sclavo, Inc.. The 510(k) number is K850212.

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

ISOENZYME TEST CK-MB received FDA 510(k) clearance on 1985-02-07, under 510(k) number K850212.

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

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

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

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

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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

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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