Medical Device Manufacturer · US , Walker , MI

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

17 submissions · 17 cleared · Since 1984

Total

Cleared

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.

Labsystems, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

17 devices

1-12 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

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

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

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

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