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FDA 510(k)

DYNAZYME-II TM LDH-L 340 KIT

K-Number: K761343 · 1977-01-05

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

Device Summary

DYNAZYME-II TM LDH-L 340 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 K761343. The device is classified under product code CFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNAZYME-II TM LDH-L 340 KIT?

DYNAZYME-II TM LDH-L 340 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 K761343.

When did DYNAZYME-II TM LDH-L 340 KIT receive FDA 510(k) clearance?

DYNAZYME-II TM LDH-L 340 KIT received FDA 510(k) clearance on 1977-01-05, under 510(k) number K761343.

Who is the listed applicant for DYNAZYME-II TM LDH-L 340 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 LDH-L 340 KIT?

The FDA product code for DYNAZYME-II TM LDH-L 340 KIT is CFJ.

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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: CFJ)

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.

K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K091544S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017Alfa Wassermann, Inc.K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.K974859LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30Diagnostic Chemicals , Ltd.K973589LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,K970684LACTATE DEHYDROGENASE (LD)Randox Laboratories, Ltd.

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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