Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
280 devices
Cleared
Aug 17, 1992
MODIFICATION COLUMNMATE
Hematology
186d
Cleared
Jul 23, 1992
REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175
Chemistry
83d
Cleared
Jul 10, 1992
COLUMNMATE II
Hematology
93d
Cleared
Jun 29, 1992
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
Hematology
94d
Cleared
Jun 19, 1992
KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024
Chemistry
112d
Cleared
Jun 09, 1992
GLYCO-TEK AFFINITY COLUMN KIT
Hematology
89d
Cleared
Jun 09, 1992
CASCADE 480
Hematology
81d
Cleared
May 07, 1992
KEMTROL SERUM CONTROL-ABNORMAL
Chemistry
69d
Cleared
May 01, 1992
THROMBIN CLOTTING TIME REAGENT
Hematology
109d
Cleared
Mar 04, 1992
COAGULATION ARPR,CAT.NO.5185
Hematology
121d
Cleared
Feb 14, 1992
ELLAGIC ACID APTT REAGENT
Hematology
74d
Cleared
Jan 13, 1992
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
Hematology
76d
Cleared
Dec 17, 1991
COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
Hematology
141d
Cleared
Nov 27, 1991
REP(R) SPE TEMPLATE 30, 16, & 8
Chemistry
93d
Cleared
Oct 30, 1991
REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172
Chemistry
112d
Cleared
Aug 22, 1991
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
Hematology
142d
Cleared
Aug 22, 1991
ARACHIDONIC ACID
Hematology
59d
Cleared
Aug 16, 1991
PACKS-4 (TM) ANALYZER
Hematology
88d
Cleared
Jul 30, 1991
REP ALP-15, 8, & 4 KITS
Chemistry
50d
Cleared
Jul 17, 1991
REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165
Chemistry
82d
Cleared
Jul 03, 1991
COLOCARE
Hematology
226d
Cleared
Jul 03, 1991
COLOSCREEN
Hematology
114d
Cleared
May 20, 1991
EPINEPHRINE REAGENT, CAT. NO. 5367
Hematology
94d
Cleared
May 20, 1991
COLLAGEN REAGENT CAT. NO. 5368
Hematology
89d
Cleared
May 20, 1991
ADP REAGENT
Hematology
84d
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