Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
280 devices
Cleared
Aug 31, 1989
REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187
Chemistry
48d
Cleared
Jul 20, 1989
REP(TM) CK-2 STAT KIT, CAT. NO. 3074
Chemistry
87d
Cleared
Jun 20, 1989
REP(TM) LD-2 STAT KIT, CAT. NO. 3078
Chemistry
64d
Cleared
Jun 20, 1989
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
Hematology
54d
Cleared
Jun 19, 1989
REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171
Chemistry
53d
Cleared
Jun 09, 1989
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178
Chemistry
60d
Cleared
Jun 09, 1989
REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181
Chemistry
43d
Cleared
Jun 07, 1989
HELENA THROMBOPLASTIN REAGENT
Hematology
70d
Cleared
Apr 12, 1989
TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER
Immunology
21d
Cleared
Mar 22, 1989
TITAN GEL IFE TRIVALENT ANTISERUM
Immunology
16d
Cleared
Mar 22, 1989
MID-LEVEL IGG KIT CAT. NO. 9315
Immunology
9d
Cleared
Feb 23, 1989
TITAN GEL ALKALINE PHOSPHATASE (HR)
Chemistry
57d
Cleared
Dec 27, 1988
LABILE LYSING REAGENT
Hematology
75d
Cleared
Dec 14, 1988
PUMPETTE(TM)
Chemistry
76d
Cleared
Sep 30, 1988
REP GLYCO SYSTEM
Hematology
150d
Cleared
Sep 30, 1988
HELENA COLOCARE
Hematology
86d
Cleared
Aug 25, 1988
OWREN'S VERONAL BUFFER
Hematology
9d
Cleared
Aug 08, 1988
REP HDL ELECTROPHORESIS METHOD
Chemistry
61d
Cleared
Jul 08, 1988
REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170
Chemistry
67d
Cleared
Jun 20, 1988
HELENA REP GEL PROCESSOR
Chemistry
27d
Cleared
Jun 01, 1988
REP LIPO KIT CAT. NO 3180
Chemistry
34d
Cleared
May 06, 1988
TITAN GEL-PC GLYCO-HEME(TM) SYSTEM
Hematology
74d
Cleared
Apr 21, 1988
HBF DILUENT
Hematology
64d
Cleared
Feb 19, 1988
FACTOR VIII REFERENCE PLASMA
Hematology
25d
Cleared
Nov 24, 1987
TITAN GEL REP LDH-30 HV
Chemistry
42d
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