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FDA 510(k)

DYNAZYME TM II CARDIAK-MB

K-Number: K772172 · 1977-12-06

ApplicantJ.T. Baker Chemical Co.
Decision Date1977-12-06
Product CodeJHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DYNAZYME TM II CARDIAK-MB is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1977-12-06 under 510(k) number K772172. 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 DYNAZYME TM II CARDIAK-MB?

DYNAZYME TM II CARDIAK-MB is a medical device that received FDA 510(k) clearance on 1977-12-06. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K772172.

When did DYNAZYME TM II CARDIAK-MB receive FDA 510(k) clearance?

DYNAZYME TM II CARDIAK-MB received FDA 510(k) clearance on 1977-12-06, under 510(k) number K772172.

Who is the listed applicant for DYNAZYME TM II CARDIAK-MB?

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

What is the FDA product code for DYNAZYME TM II CARDIAK-MB?

The FDA product code for DYNAZYME TM II CARDIAK-MB is JHW.

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Other records listing J.T. Baker 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.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

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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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