510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Labsystems, Inc.

Walker, MI, US

Labsystems, Inc. appears in FDA device records in Walker, MI. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
17
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 17 510(k) clearances for Labsystems, Inc. between 1984 and 1993. The busiest year on record is 1986, with 5. The most recent is 1993, with 1.

Clearances by year, as a table
510(k) clearance decisions for Labsystems, Inc., by decision year
YearClearances
19844
19865
19873
19881
19892
19901
19931
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K923365TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEMITISubstantially Equivalent
K896474RESUBMITTED FECATWIN SENSITIVE - FECA-EIAKHESubstantially Equivalent
K890154MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIALGDSubstantially Equivalent
K890091MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KITLFXSubstantially Equivalent
K881243RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201LFXSubstantially Equivalent
K873780MODIFICATION RUBELLA IGM EIA TEST KITLFXSubstantially Equivalent
K873583AUTO-EIAJJQSubstantially Equivalent
K872252MODIFIED TOXOPLASMA GONDII IGG EIA TEST KITLGDSubstantially Equivalent
K862705CYTOMEGALOVIRUS IGG EIA TEST KITGQISubstantially Equivalent
K862431RUBELLA IGM EIA TEST KITLFXSubstantially Equivalent
K862216TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)LGDSubstantially Equivalent
K853696RUBELLA IGG EIA TEST KITLFXSubstantially Equivalent
K843189CYTOMEGALOVIRUS IGG EIA TEST KITGQISubstantially Equivalent
K842797TOXOPLASMA GONDII IGM EIA TEST KITLGDSubstantially Equivalent
K842773LABSYSTEMS FP-901 CHEMISTRY ANALYZERJJESubstantially Equivalent
K833829TOXOPLASMA GOND II IGG DIA TEST KITLGDSubstantially Equivalent
K841214LABSYSTEMS UNISKANJJQSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain