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FDA 510(k)

CREATINE PHROSPHOKINASE (CK) PROCEDURE

K-Number: K861665 · 1986-06-05

ApplicantData Medical Associates, Inc.
Decision Date1986-06-05
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE PHROSPHOKINASE (CK) PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1986-06-05 under 510(k) number K861665. 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 CREATINE PHROSPHOKINASE (CK) PROCEDURE?

CREATINE PHROSPHOKINASE (CK) PROCEDURE is a medical device that received FDA 510(k) clearance on 1986-06-05. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K861665.

When did CREATINE PHROSPHOKINASE (CK) PROCEDURE receive FDA 510(k) clearance?

CREATINE PHROSPHOKINASE (CK) PROCEDURE received FDA 510(k) clearance on 1986-06-05, under 510(k) number K861665.

Who is the listed applicant for CREATINE PHROSPHOKINASE (CK) PROCEDURE?

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

What is the FDA product code for CREATINE PHROSPHOKINASE (CK) PROCEDURE?

The FDA product code for CREATINE PHROSPHOKINASE (CK) PROCEDURE is CGS.

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Other records listing Data Medical Associates, Inc. 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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