Instrumentation Laboratory CO - FDA 510(k) Cleared Devices
321
Total
320
Cleared
1
Denied
FDA 510(k) cleared devices by Instrumentation Laboratory CO Immunology ✕
25 devices
Cleared
May 21, 2010
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I
Immunology
359d
Cleared
Mar 11, 2010
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
Immunology
233d
Cleared
May 10, 2004
QUANTEX FERRITIN
Immunology
35d
Cleared
Feb 24, 2003
BIORAPID MONONUCLEOSIS
Immunology
34d
Cleared
Sep 27, 2001
COLOR-MONOGEN
Immunology
29d
Cleared
Oct 22, 1997
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
Immunology
40d
Cleared
Sep 26, 1996
QUANTEX C4
Immunology
111d
Cleared
Sep 26, 1996
QUANTEX IGG
Immunology
111d
Cleared
Sep 25, 1996
QUANTEX C3
Immunology
110d
Cleared
Sep 25, 1996
QUANTEX IGA
Immunology
110d
Cleared
Sep 25, 1996
QUANTEX IGM
Immunology
110d
Cleared
May 15, 1995
IL TEST BETA-2MICROGLOBULIN
Immunology
290d
Cleared
Feb 05, 1993
IL TEST CALIBRATION SET APO A1B
Immunology
225d
Cleared
Oct 26, 1992
IL TEST APOLIPOROTEIN B (APO B)
Immunology
123d
Cleared
Oct 26, 1992
IL TEST APOLIPOPROTEIN A1
Immunology
123d
Cleared
Jul 29, 1992
IL TEST(TM) HAPTOGLOBIN (HPT)
Immunology
212d
Cleared
Jul 29, 1992
IL TEST ALPHA-1-ANTITRYPSIN (AAT)
Immunology
209d
Cleared
Jun 16, 1992
IL TEST COMPLEMENT 3
Immunology
166d
Cleared
Jun 16, 1992
IL TEST IMMUNOGLOBULIN A
Immunology
166d
Cleared
Mar 13, 1992
IL TEST IMMUNOGLOBULIN G (IGG)
Immunology
71d
Cleared
Mar 13, 1992
IL TEST COMPLEMENT 4
Immunology
71d
Cleared
Mar 11, 1992
IL TEST IMMUNOGLOBULIN M (IGM)
Immunology
69d
Cleared
Jan 17, 1992
IL TEST(TM) TRANSFERRIN (TRF)
Immunology
71d
Cleared
Nov 29, 1991
IL TEST(TM DIGOXIN
Immunology
74d
Cleared
Oct 03, 1980
F/LS MCA APPLICATION SOFTWARE
Immunology
101d