Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
280 devices
Cleared
May 12, 1998
COLOSCREEN-ES
Hematology
81d
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
Cleared
Oct 01, 1997
REP SPE VIS-60/40 KIT
Chemistry
28d
Cleared
Jan 13, 1997
REP 3 QUTO-FLUR CHOLESTEROL-30
Chemistry
171d
Cleared
Dec 23, 1996
REP 3 FLUR SPE-60 KIT
Chemistry
47d
Cleared
Dec 23, 1996
REP FLUR CHOLESTEROL-60 KIT
Chemistry
46d
Cleared
Dec 10, 1996
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451
Hematology
208d
Cleared
Oct 25, 1996
RAPID ELECTROPHORESIS ANALYZER
Chemistry
260d
Cleared
Mar 11, 1996
PORCINE FACTOR VIII
Hematology
298d
Cleared
Feb 14, 1996
CHROM Z-HEPARIN, CAT. NO 5242
Hematology
247d
Cleared
Feb 09, 1996
CHROM Z-F:VIII, CAT. NO. 5241
Hematology
242d
Cleared
Jan 30, 1996
CHROM Z-PROTEIN C, CAT. NO. 5243
Hematology
232d
Cleared
Dec 07, 1995
CHROM Z-PLASMINOGEN, CAT. NO. 5244
Hematology
178d
Cleared
Nov 13, 1995
CHROM Z CHROMOGENIC ASSAYS
Hematology
201d
Cleared
Oct 20, 1995
THROMBOPLASTIN-LI REAGENT
Hematology
183d
Cleared
Sep 08, 1995
ADP REAGENT, MODIFIED
Hematology
116d
Cleared
Sep 01, 1995
CASCASE 480 SNSLYZER
Hematology
182d
Cleared
Jul 11, 1995
COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN
Chemistry
200d
Cleared
Mar 30, 1995
REP CHOLESTEROL PROFILE CONTROL
Chemistry
49d
Cleared
Mar 30, 1995
CARDIO REP LD CONTROL - CAT NO. 3325
Chemistry
37d
Cleared
Dec 02, 1994
APTT-ES
Hematology
402d
Cleared
Nov 21, 1994
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
Hematology
217d
Looking for a specific device from Helena Laboratories? Search by device name or K-number.
Search all Helena Laboratories devices