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FDA 510(k)

DYNAZYME-II TM CK-230 KIT

K-Number: K761344 · 1977-01-05

ApplicantJ.T. Baker Chemical Co.
Decision Date1977-01-05
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DYNAZYME-II TM CK-230 KIT 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 1977-01-05 under 510(k) number K761344. 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 DYNAZYME-II TM CK-230 KIT?

DYNAZYME-II TM CK-230 KIT is a medical device that received FDA 510(k) clearance on 1977-01-05. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K761344.

When did DYNAZYME-II TM CK-230 KIT receive FDA 510(k) clearance?

DYNAZYME-II TM CK-230 KIT received FDA 510(k) clearance on 1977-01-05, under 510(k) number K761344.

Who is the listed applicant for DYNAZYME-II TM CK-230 KIT?

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-II TM CK-230 KIT?

The FDA product code for DYNAZYME-II TM CK-230 KIT is CGS.

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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 KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

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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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