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)

LACTATE DEHYDROGENASE LDH

K-Number: K883206 · 1988-09-09

ApplicantElectro-Nucleonics, Inc.
Decision Date1988-09-09
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LACTATE DEHYDROGENASE LDH is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics, Inc.. It received FDA 510(k) clearance on 1988-09-09 under 510(k) number K883206. 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 LDH?

LACTATE DEHYDROGENASE LDH is a medical device that received FDA 510(k) clearance on 1988-09-09. The listed applicant is Electro-Nucleonics, Inc.. The 510(k) number is K883206.

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

LACTATE DEHYDROGENASE LDH received FDA 510(k) clearance on 1988-09-09, under 510(k) number K883206.

Who is the listed applicant for LACTATE DEHYDROGENASE LDH?

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

What is the FDA product code for LACTATE DEHYDROGENASE LDH?

The FDA product code for LACTATE DEHYDROGENASE LDH 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 Electro-Nucleonics, 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.

K893718DELTATEST (R) LIPASE IIK883670SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VIK883427VIRGO(R) VZV-IGG ELISAK883282VIRGO HSV-1 IGG ELISAK883281VIRGO HSV-2 IGG ELISAK883102VIRGO (R) CMV-IGG ELISA

View all 9 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.

↑