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FDA 510(k)

UNIFAST CK-MB

K-Number: K873134 · 1987-09-16

ApplicantSclavo, Inc.
Decision Date1987-09-16
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNIFAST 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 1987-09-16 under 510(k) number K873134. 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 UNIFAST CK-MB?

UNIFAST CK-MB is a medical device that received FDA 510(k) clearance on 1987-09-16. The listed applicant is Sclavo, Inc.. The 510(k) number is K873134.

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

UNIFAST CK-MB received FDA 510(k) clearance on 1987-09-16, under 510(k) number K873134.

Who is the listed applicant for UNIFAST 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 UNIFAST CK-MB?

The FDA product code for UNIFAST CK-MB is CGS.

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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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