Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
122 devices
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
Feb 23, 1989
TITAN GEL ALKALINE PHOSPHATASE (HR)
Chemistry
57d
Cleared
Dec 14, 1988
PUMPETTE(TM)
Chemistry
76d
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
Nov 24, 1987
TITAN GEL REP LDH-30 HV
Chemistry
42d
Cleared
Nov 24, 1987
TITAN GEL REP LDH-6 HV
Chemistry
42d
Cleared
Nov 23, 1987
TITAN GEL REP LDH-12 HV
Chemistry
41d
Cleared
Nov 23, 1987
TITAN GEL REP CPK-6 HV
Chemistry
41d
Cleared
Nov 05, 1987
TITAN GEL REP CPK-12 HV
Chemistry
23d
Cleared
Nov 04, 1987
TITAN GEL REP CPK/LDH ISOENZYME CONTROL
Chemistry
22d
Cleared
Nov 03, 1987
TITAN GEL REP CPK-30 HV
Chemistry
21d
Cleared
Nov 03, 1987
TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED.
Chemistry
21d
Cleared
Oct 20, 1987
TITAN GEL LDH REP SYSTEM
Chemistry
57d
Cleared
Oct 20, 1987
TITAN GEL CPK REP SYSTEM
Chemistry
57d
Cleared
Oct 02, 1987
TITAN GEL HDL CHOLESTEROL KIT
Chemistry
31d
Cleared
Sep 08, 1987
RAPID ELECTROPHORESIS SYSTEM (REP)
Chemistry
19d
Cleared
Jun 01, 1987
ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT
Chemistry
88d
Cleared
Apr 29, 1987
TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091
Chemistry
50d
Cleared
Apr 22, 1987
TITAN GEL MULTI-SLOT LIPO-17 SYSTEM
Chemistry
19d
Cleared
Dec 17, 1986
ELECTROPHORESIS DATA CENTER (EDC)
Chemistry
300d
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