Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
122 devices
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
Cleared
May 29, 1986
CK/LD BUFFER (CAT. NO. 5808)
Chemistry
23d
Cleared
Oct 22, 1985
EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE
Chemistry
139d
Cleared
Oct 01, 1985
EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
Chemistry
118d
Cleared
Nov 09, 1984
TITAN GEL ISO DOT LDH KIT
Chemistry
122d
Cleared
Sep 28, 1984
TITAN GEL ISO DOT CPK PROCEDURE
Chemistry
74d
Cleared
Mar 15, 1984
TITAN GEL LIPOPROTEIN ELECTROPHORESIS
Chemistry
154d
Cleared
Jan 18, 1984
AUTO AIC ANALYZER SYSTEM
Chemistry
83d
Cleared
Jan 13, 1984
HELENA BIO STRIP OB
Chemistry
25d
Cleared
Jan 04, 1984
TITANGEL HIGH RESOLUTION CONTROL
Chemistry
79d
Cleared
Sep 12, 1983
BIO SURE STAIN
Chemistry
47d
Cleared
Aug 08, 1983
BIOCHECK POSITIVE URINE CONTROL
Chemistry
48d
Cleared
Jul 07, 1983
TITAN GE/IEPLATE
Chemistry
50d
Cleared
May 13, 1983
HELENA BIOSTRIP A
Chemistry
45d
Cleared
May 05, 1983
HELENA BIOSTRIP PH
Chemistry
37d
Cleared
May 04, 1983
HELENA BIOSTRIP K
Chemistry
36d
Cleared
Apr 28, 1983
HELENA BIOSTRIP P
Chemistry
30d
Cleared
Apr 12, 1983
NEGATIVE URINE CONTROL
Chemistry
27d
Cleared
Apr 12, 1983
TITAN GEL LDH ISO-ENZYME CONTROL
Chemistry
25d
Cleared
Dec 22, 1982
TITAN GEL LDH ISOENZYME KIT
Chemistry
169d
Cleared
Nov 01, 1982
TITAN GEL CPK ISOENZYME SYSTEM
Chemistry
105d
Cleared
Aug 27, 1982
STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO
Chemistry
45d
Cleared
Aug 16, 1982
TITAN GEL SERUM CONTROL
Chemistry
41d
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