Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

REAGENT, LACTATE DEHYDROGENASE

K-Number: K760476 · 1976-11-01

ApplicantSimmler & Son, Inc.
Decision Date1976-11-01
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT, LACTATE DEHYDROGENASE is the device name listed in this FDA 510(k) record. The listed applicant is Simmler & Son, Inc.. It received FDA 510(k) clearance on 1976-11-01 under 510(k) number K760476. 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 REAGENT, LACTATE DEHYDROGENASE?

REAGENT, LACTATE DEHYDROGENASE is a medical device that received FDA 510(k) clearance on 1976-11-01. The listed applicant is Simmler & Son, Inc.. The 510(k) number is K760476.

When did REAGENT, LACTATE DEHYDROGENASE receive FDA 510(k) clearance?

REAGENT, LACTATE DEHYDROGENASE received FDA 510(k) clearance on 1976-11-01, under 510(k) number K760476.

Who is the listed applicant for REAGENT, LACTATE DEHYDROGENASE?

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

What is the FDA product code for REAGENT, LACTATE DEHYDROGENASE?

The FDA product code for REAGENT, LACTATE DEHYDROGENASE is CFJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Simmler & Son, 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.

K780817GLOBIN-TERGEK771903LIPASEK771904GLYCEROL KINASEK771905GLYCEROL SUBSTRATEK771906PHOSPHATEK761086REAGENTS

View all 14 devices →

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.

↑