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FDA 510(k)

CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS

K-Number: K871677 · 1987-05-12

ApplicantCatachem, Inc.
Decision Date1987-05-12
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Catachem, Inc.. It received FDA 510(k) clearance on 1987-05-12 under 510(k) number K871677. The device is classified under product code JHY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS?

CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1987-05-12. The listed applicant is Catachem, Inc.. The 510(k) number is K871677.

When did CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS receive FDA 510(k) clearance?

CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS received FDA 510(k) clearance on 1987-05-12, under 510(k) number K871677.

Who is the listed applicant for CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS?

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

What is the FDA product code for CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS?

The FDA product code for CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS is JHY.

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Other records listing Catachem, 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.

K062503CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITK945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERK903341MAGNESIUMK902326AMYLASE FOR MANUAL/AUTOMATED APPLICATIONSK902877TOTAL IRON FOR MANUAL/AUTOMATED

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Related Devices (Code: JHY)

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.

K132571ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAYRoche DiagnosticsK070835OLYMPUS CK-MB REAGENTOlympus Life & Material Science Europa GmbH (IrishK022757SPIFE CK KIT, MODEL 3332, 3333Helena LaboratoriesK022654MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MBRoche Diagnostics Corp.K974421ELECSYS CK-MB STATBoehringer Mannheim Corp.K970343MMB METHODDade Chemistry Systems, Inc.

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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