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FDA 510(k)

CREATINE KINASE (COLORIMETRIC METHOD)

K-Number: K880178 · 1988-02-18

ApplicantTech-Co, Inc.
Decision Date1988-02-18
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE (COLORIMETRIC METHOD) is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Co, Inc.. It received FDA 510(k) clearance on 1988-02-18 under 510(k) number K880178. 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 (COLORIMETRIC METHOD)?

CREATINE KINASE (COLORIMETRIC METHOD) is a medical device that received FDA 510(k) clearance on 1988-02-18. The listed applicant is Tech-Co, Inc.. The 510(k) number is K880178.

When did CREATINE KINASE (COLORIMETRIC METHOD) receive FDA 510(k) clearance?

CREATINE KINASE (COLORIMETRIC METHOD) received FDA 510(k) clearance on 1988-02-18, under 510(k) number K880178.

Who is the listed applicant for CREATINE KINASE (COLORIMETRIC METHOD)?

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

What is the FDA product code for CREATINE KINASE (COLORIMETRIC METHOD)?

The FDA product code for CREATINE KINASE (COLORIMETRIC METHOD) is JHY.

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Other records listing Tech-Co, 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.

K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTK923376VISUAL HCG PREGNANCY TESTK920766T4 EIA BEAD ASSAYK920716DIRECT PREGNANCY TESTK902574POTASSIUM REAGENT SETK901561IRON/TOTAL IRON BINDING CAPACITY

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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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