TITAN GEL LDH ISOENZYME KIT— 510(k) K821983

Name: FDA 510(k) clearance K821983
Creator: U.S. Food and Drug Administration
Published: 1982-12-22

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K821983 for TITAN GEL LDH ISOENZYME KIT, Substantially Equivalent on 1982-12-22. Applicant: Helena Laboratories. Device class: 2.

Clearance details

Applicant: Helena Laboratories
Product code: Code CEX
Device class: Class 2
Regulation: 21 CFR 862.1445
Advisory panel: Clinical Chemistry
Date received: 1982-07-06
Decision date: 1982-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEX

view all

K872891 — LACTATE DEHYDROGENASE ISOENZYME 11987-09-16
K851521 — LD-1(IMMUNO) SEPARATION SET1985-05-10
K842018 — ISO-SEP SYSTEM1984-09-28
K821879 — ULTRACHEM T.P.1982-07-14
K800129 — CENTRIFICHEM CREATININE1980-02-13

More clearances from Helena Laboratories

view all

K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL2013-10-07
K100103 — SPECIALTY ASSAYED CONTROL-22010-12-15
K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA2007-02-23
K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 34582006-07-06
K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP2006-05-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.