Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
122 devices
Cleared
Oct 11, 2002
SPIFE CK KIT, MODEL 3332, 3333
Chemistry
52d
Cleared
Oct 01, 2002
SPIFE LD-12 KIT, MODEL 3338
Chemistry
67d
Cleared
Aug 15, 2002
SPIFE LIPPOROTEIN-12, MODEL 3344
Chemistry
28d
Cleared
May 06, 2002
SPIFE 2000/3000 ALP 40, 20
Chemistry
69d
Cleared
Mar 29, 2002
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
Chemistry
45d
Cleared
Dec 21, 2001
SPIFE 2000/3000 LIPOPROTEIN
Chemistry
64d
Cleared
Apr 17, 2000
SPIFE CHOLESTEROL PROFILE KIT
Chemistry
54d
Cleared
Oct 18, 1999
REP CHOLESTEROL PROFILE KIT
Chemistry
45d
Cleared
May 01, 1998
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8
Chemistry
71d
Cleared
Jan 06, 1998
REP CHOLESTEROL PROFILE CONTROL-II
Chemistry
27d
Cleared
Jan 02, 1998
SPIFE IFE-6
Chemistry
141d
Cleared
Oct 27, 1997
SPIFE
Chemistry
131d
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