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FDA 510(k)

CREATINE KINASE MB ISOENZYME IMMUNO UV

K-Number: K810861 · 1981-04-14

ApplicantThe Dow Chemical Co.
Decision Date1981-04-14
Product CodeJHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE MB ISOENZYME IMMUNO UV is the device name listed in this FDA 510(k) record. The listed applicant is The Dow Chemical Co.. It received FDA 510(k) clearance on 1981-04-14 under 510(k) number K810861. The device is classified under product code JHW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATINE KINASE MB ISOENZYME IMMUNO UV?

CREATINE KINASE MB ISOENZYME IMMUNO UV is a medical device that received FDA 510(k) clearance on 1981-04-14. The listed applicant is The Dow Chemical Co.. The 510(k) number is K810861.

When did CREATINE KINASE MB ISOENZYME IMMUNO UV receive FDA 510(k) clearance?

CREATINE KINASE MB ISOENZYME IMMUNO UV received FDA 510(k) clearance on 1981-04-14, under 510(k) number K810861.

Who is the listed applicant for CREATINE KINASE MB ISOENZYME IMMUNO UV?

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

What is the FDA product code for CREATINE KINASE MB ISOENZYME IMMUNO UV?

The FDA product code for CREATINE KINASE MB ISOENZYME IMMUNO UV is JHW.

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Other records listing The Dow Chemical Co. 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.

K823474ENZYMATIC GLUCOSE DETERMINATIONK822154UREA NITROGEN (ENZYMATIC) DETERMINATIONK821536DOWFLOW ALT-UV DETERMINATIONK821315DOWFLOW ENZYMATIC TRIGLYCERIDES DETERMK820675BILIRUBIN(TOTAL) DETERMINATION CTMSK820714DOW BILIRUBIN(DIRECT) DETERMINATION

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Related Devices (Code: JHW)

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.

K162526Creatine Kinase-MBRoche DiagnosticsK122083ELITECH CLINICAL SYSTEMS CK NAC SLElitechgroupK023744WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354Wiener Laboratories SaicK003158ROCHE DIAGNOSTICS CK-MBRoche Diagnostics Corp.K961501ELECSYS CK-MBBoehringer Mannheim Corp.K950186CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMMiles, 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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