Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
21 devices
Cleared
Oct 07, 2013
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
Immunology
138d
Cleared
Jul 06, 2006
SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL...
Immunology
80d
Cleared
Feb 19, 2003
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
Immunology
64d
Cleared
Mar 15, 2001
SPIFE IFE CALIBRATOR AND CONTROL KIT
Immunology
14d
Cleared
Jun 28, 1999
POLYSLIT IFE KIT
Immunology
95d
Cleared
Nov 04, 1998
SPIFE URINE IFE
Immunology
98d
Cleared
Apr 27, 1993
TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067
Immunology
47d
Cleared
Nov 02, 1992
REP IMMUNOFIX
Immunology
102d
Cleared
Jan 03, 1991
TITAN GEL
Immunology
49d
Cleared
Jun 06, 1990
REP(R) IMMUNOFIX
Immunology
47d
Cleared
Feb 27, 1990
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
Immunology
28d
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
Aug 12, 1987
TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410
Immunology
26d
Cleared
Apr 29, 1987
TITAN GEL IMMUNOFIX CONTROLS
Immunology
13d
Cleared
Apr 22, 1987
PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS
Immunology
16d
Cleared
Nov 21, 1983
COLOSCREEN V.P.I.
Immunology
90d
Cleared
Mar 24, 1983
TITAN IMMUNO-FIX
Immunology
28d
Cleared
Jul 02, 1981
HELENA PLASMINOGEN QUIPLATE PROCEDURE
Immunology
9d
Cleared
May 23, 1979
HELENA QUIPLATE SYSTEM
Immunology
54d