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FDA 510(k)

LDH REAGENT SYSTEM

K-Number: K781765 · 1978-11-22

ApplicantAmerican Monitor Corp.
Decision Date1978-11-22
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LDH REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1978-11-22 under 510(k) number K781765. 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 LDH REAGENT SYSTEM?

LDH REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1978-11-22. The listed applicant is American Monitor Corp.. The 510(k) number is K781765.

When did LDH REAGENT SYSTEM receive FDA 510(k) clearance?

LDH REAGENT SYSTEM received FDA 510(k) clearance on 1978-11-22, under 510(k) number K781765.

Who is the listed applicant for LDH REAGENT SYSTEM?

The FDA 510(k) record lists American Monitor Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LDH REAGENT SYSTEM?

The FDA product code for LDH REAGENT SYSTEM is CFJ.

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Other records listing American Monitor Corp. 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.

K895999PHOSPHORUSK896000ASPARTATE AMINOTRANFERASE (AST)K896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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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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