Medical Device Manufacturer · US , Walker , MI

Labsystems, Inc. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 1984
17
Total
17
Cleared
0
Denied

Labsystems, Inc. has 17 FDA 510(k) cleared medical devices. Based in Walker, US.

Historical record: 17 cleared submissions from 1984 to 1993. Primary specialty: Microbiology.

Browse the FDA 510(k) cleared devices submitted by Labsystems, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Labsystems, Inc.

17 devices
1-17 of 17
Cleared Mar 24, 1993
TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM
K923365 · ITI
Physical Medicine · 259d
Cleared Jan 25, 1990
RESUBMITTED FECATWIN SENSITIVE - FECA-EIA
K896474 · KHE
Hematology · 73d
Cleared Feb 07, 1989
MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA
K890154 · LGD
Microbiology · 26d
Cleared Feb 03, 1989
MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT
K890091 · LFX
Microbiology · 29d
Cleared Apr 04, 1988
RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201
K881243 · LFX
Microbiology · 14d
Cleared Oct 15, 1987
MODIFICATION RUBELLA IGM EIA TEST KIT
K873780 · LFX
Microbiology · 35d
Cleared Sep 22, 1987
AUTO-EIA
K873583 · JJQ
Chemistry · 19d
Cleared Jul 01, 1987
MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT
K872252 · LGD
Microbiology · 20d
Cleared Oct 01, 1986
CYTOMEGALOVIRUS IGG EIA TEST KIT
K862705 · GQI
Microbiology · 77d
Cleared Aug 08, 1986
RUBELLA IGM EIA TEST KIT
K862431 · LFX
Microbiology · 43d
Cleared Jun 30, 1986
TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)
K862216 · LGD
Microbiology · 20d
Cleared Jun 17, 1986
RUBELLA IGG EIA TEST KIT
K853696 · LFX
Microbiology · 285d
Cleared Jan 08, 1986
CYTOMEGALOVIRUS IGG EIA TEST KIT
K843189 · GQI
Immunology · 513d
Cleared Oct 17, 1984
TOXOPLASMA GONDII IGM EIA TEST KIT
K842797 · LGD
Microbiology · 92d
Cleared Sep 04, 1984
LABSYSTEMS FP-901 CHEMISTRY ANALYZER
K842773 · JJE
Chemistry · 50d
Cleared Apr 24, 1984
TOXOPLASMA GOND II IGG DIA TEST KIT
K833829 · LGD
Microbiology · 173d
Cleared Apr 13, 1984
LABSYSTEMS UNISKAN
K841214 · JJQ
Chemistry · 22d
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