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FDA 510(k)

CREATINE KINASE (CK) REAGENT SET

K-Number: K930660 · 1993-03-29

ApplicantPointe Scientific, Inc.,
Decision Date1993-03-29
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE (CK) REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 1993-03-29 under 510(k) number K930660. 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 KINASE (CK) REAGENT SET?

CREATINE KINASE (CK) REAGENT SET is a medical device that received FDA 510(k) clearance on 1993-03-29. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K930660.

When did CREATINE KINASE (CK) REAGENT SET receive FDA 510(k) clearance?

CREATINE KINASE (CK) REAGENT SET received FDA 510(k) clearance on 1993-03-29, under 510(k) number K930660.

Who is the listed applicant for CREATINE KINASE (CK) REAGENT SET?

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

What is the FDA product code for CREATINE KINASE (CK) REAGENT SET?

The FDA product code for CREATINE KINASE (CK) REAGENT SET is CGS.

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Other records listing Pointe Scientific, Inc., 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.

K070757MICROPROTEIN REAGENT SETK062118POINTE 360K070251CARBON DIOXIDE LIQUID STABLE REAGENTK070207MULTI-ANALYTE CHEMISTRY CALIBRATORK070504AMMONIA/ALCOHOL CONTROL SETK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

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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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