IMMULITE DIGITOXIN— 510(k) K943235

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K943235 for IMMULITE DIGITOXIN, Substantially Equivalent on 1994-10-27. Applicant: Diagnostic Products Corp.. Device class: 2.

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code LFM
Device class: Class 2
Regulation: 21 CFR 862.3300
Advisory panel: Clinical Toxicology
Date received: 1994-07-06
Decision date: 1994-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFM

K062024 — DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE2006-07-28
K012112 — RANDOX DIGITOXIN2002-01-11
K990251 — DGTX FLEX REAGENT CARTRIDGE, MODEL DF361999-03-31
K970546 — ACS DIGITOXIN1997-07-14
K963158 — ABBOTT AXSYM DIGITOXIN (MODIFY)1996-09-10

More clearances from Diagnostic Products Corp.

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