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FDA 510(k)

COULTER CK (CREATINE KINASE) REAGENT

K-Number: K901267 · 1990-05-23

ApplicantCoulter Corp.
Decision Date1990-05-23
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULTER CK (CREATINE KINASE) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Corp.. It received FDA 510(k) clearance on 1990-05-23 under 510(k) number K901267. 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 COULTER CK (CREATINE KINASE) REAGENT?

COULTER CK (CREATINE KINASE) REAGENT is a medical device that received FDA 510(k) clearance on 1990-05-23. The listed applicant is Coulter Corp.. The 510(k) number is K901267.

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

COULTER CK (CREATINE KINASE) REAGENT received FDA 510(k) clearance on 1990-05-23, under 510(k) number K901267.

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

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

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

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

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Other records listing Coulter Corp. 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.

K993356COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSESK991070COULTER Z2 ANALYZERK990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSK990172TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLAK990352COULTER AC T DIFF 2 ANALYZERK984216IMMUNO-TROL CONTROL CELLS

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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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