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FDA 510(k)

EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE

K-Number: K852391 · 1985-10-01

ApplicantHelena Laboratories
Decision Date1985-10-01
Product CodeCFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1985-10-01 under 510(k) number K852391. The device is classified under product code CFH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE?

EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE is a medical device that received FDA 510(k) clearance on 1985-10-01. The listed applicant is Helena Laboratories. The 510(k) number is K852391.

When did EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE receive FDA 510(k) clearance?

EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE received FDA 510(k) clearance on 1985-10-01, under 510(k) number K852391.

Who is the listed applicant for EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE?

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

What is the FDA product code for EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE?

The FDA product code for EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE is CFH.

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Other records listing Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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Related Devices (Code: CFH)

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.

K050790SPOTCHEM II LDH TESTArkray, Inc.K020484CARESIDE LDHCareside, Inc.K895138CLINISTAT LDH REAGENT TESTHeraeus Kulzer, Inc.K894578IQ LDHBd Becton Dickinson Vacutainer Systems PreanalyticK880630LACTATE DEHYDROGENASE (LDH-L)Tech-Co, Inc.K860349LACTATE DEHYDROGENASE (LDH) REAGENT SETSterling Diagnostics, Inc.

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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