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FDA 510(k)

SPIN CHEM REAGENT, DETERMINATION OF LDH-

K-Number: K791081 · 1979-07-17

ApplicantSmithkline Diagnostics, Inc.
Decision Date1979-07-17
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPIN CHEM REAGENT, DETERMINATION OF LDH- is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-07-17 under 510(k) number K791081. 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 SPIN CHEM REAGENT, DETERMINATION OF LDH-?

SPIN CHEM REAGENT, DETERMINATION OF LDH- is a medical device that received FDA 510(k) clearance on 1979-07-17. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K791081.

When did SPIN CHEM REAGENT, DETERMINATION OF LDH- receive FDA 510(k) clearance?

SPIN CHEM REAGENT, DETERMINATION OF LDH- received FDA 510(k) clearance on 1979-07-17, under 510(k) number K791081.

Who is the listed applicant for SPIN CHEM REAGENT, DETERMINATION OF LDH-?

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

What is the FDA product code for SPIN CHEM REAGENT, DETERMINATION OF LDH-?

The FDA product code for SPIN CHEM REAGENT, DETERMINATION OF LDH- is CFJ.

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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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