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FDA 510(k)

KING DIAGNOSTICS LDH TEST

K-Number: K862306 · 1986-08-19

ApplicantKing Diagnostics, Inc.
Decision Date1986-08-19
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KING DIAGNOSTICS LDH TEST is the device name listed in this FDA 510(k) record. The listed applicant is King Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K862306. 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 KING DIAGNOSTICS LDH TEST?

KING DIAGNOSTICS LDH TEST is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is King Diagnostics, Inc.. The 510(k) number is K862306.

When did KING DIAGNOSTICS LDH TEST receive FDA 510(k) clearance?

KING DIAGNOSTICS LDH TEST received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862306.

Who is the listed applicant for KING DIAGNOSTICS LDH TEST?

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

What is the FDA product code for KING DIAGNOSTICS LDH TEST?

The FDA product code for KING DIAGNOSTICS LDH TEST is CFJ.

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Other records listing King Diagnostics, Inc. 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.

K933329KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENTK931834KING SODIUM/POTASSIUM STANDARD MODIFIEDK931773HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)K931326KING DIAGNOSTICS CK REAGENTK923129KING DIAGNOSTICS GLUCOSE (HK) REAGENTK922969KING DIAGNOSTICS UREA NITROGEN REAGENT

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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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