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FDA 510(k)

LACTATE DEHYDROGENASE CAT. # 320-68, 320-69

K-Number: K875206 · 1988-02-02

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1988-02-02
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1988-02-02 under 510(k) number K875206. 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 LACTATE DEHYDROGENASE CAT. # 320-68, 320-69?

LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 is a medical device that received FDA 510(k) clearance on 1988-02-02. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K875206.

When did LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 receive FDA 510(k) clearance?

LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 received FDA 510(k) clearance on 1988-02-02, under 510(k) number K875206.

Who is the listed applicant for LACTATE DEHYDROGENASE CAT. # 320-68, 320-69?

The FDA 510(k) record lists Diagnostic Chemicals, Ltd. (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LACTATE DEHYDROGENASE CAT. # 320-68, 320-69?

The FDA product code for LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 is CFJ.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CAL

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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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