Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
280 devices
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 20, 1987
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
Hematology
88d
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
Aug 25, 1987
PROTOFLUOR Z
Toxicology
131d
Cleared
Aug 12, 1987
TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410
Immunology
26d
Cleared
Jul 09, 1987
CHROM-TROL
Hematology
20d
Cleared
Jun 10, 1987
Q.I.C. BLEEDING TIME DEVICE
Hematology
68d
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 29, 1987
TITAN GEL IMMUNOFIX CONTROLS
Immunology
13d
Cleared
Apr 22, 1987
TITAN GEL MULTI-SLOT LIPO-17 SYSTEM
Chemistry
19d
Cleared
Apr 22, 1987
PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS
Immunology
16d
Cleared
Dec 17, 1986
ELECTROPHORESIS DATA CENTER (EDC)
Chemistry
300d
Cleared
Aug 26, 1986
ELECTROPHORESIS WORK CENTER (EWC)
Chemistry
133d
Cleared
Aug 19, 1986
SURESPOT
Chemistry
35d
Cleared
Jul 14, 1986
HEMAFLUOR REAGENT KIT
Chemistry
167d
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