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

Mchenry, IL, US

Syva Co. appears in FDA device records in Mchenry, IL. FDA records list 212 510(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
212
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 212

FDA records hold 212 510(k) clearances for Syva Co. between 1976 and 1985. The busiest year on record is 1982, with 48. The most recent is 1985, with 1.

Clearances by year, as a table
510(k) clearance decisions for Syva Co., by decision year
YearClearances
19762
19774
197813
197917
198023
198124
198248
198341
198439
19851
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K841190MICROTRAK HSV 1 & 2 DIRECT SPECIMANGQLSubstantially Equivalent
K843556EMIT D.A.U. COCAINE ASSAYDIOSubstantially Equivalent
K843419EMIT 700 CANNABINOID CONTROL SETLASSubstantially Equivalent
K843508EMIT 700 CONTROL SET BDIFSubstantially Equivalent
K843509EMIT 700 PHENCYCLIDINE ASSAYLCMSubstantially Equivalent
K843507EMIT 700 CALIBRATOR BDKBSubstantially Equivalent
K843420EMIT 700 CANNABINOID CALIBRATORDLJSubstantially Equivalent
K842815EMIT D.A.U. BENZODIAZEPINE ASSAYJXMSubstantially Equivalent
K842677EMIT D.A.U. OPIATE ASSAYDJGSubstantially Equivalent
K842676EMIT D.A.U. METHADONE ASSAYDJRSubstantially Equivalent
K842675EMIT D.A.U. BARBITURATE ASSAYDISSubstantially Equivalent
K842674EMIT D.A.U. AMPHETAMINE ASSAYDKZSubstantially Equivalent
K843421EMIT 700 CANNABINOID ASSAYLDJSubstantially Equivalent
K843458EMIT 700 AMPHETAMINE ASSAY NEW PRODUCTDKZSubstantially Equivalent
K843418EMIT 700 BARBITURATE ASSAYDISSubstantially Equivalent
K843162EMIT 700 OPIATE ASSAYDJGSubstantially Equivalent
K843163EMIT 700 CALIBRATOR ADKBSubstantially Equivalent
K842816EMIT D.A.U. LOW & MED. CALIBRATORS BDKBSubstantially Equivalent
K843161EMIT 700 CONTROL SET ADIFSubstantially Equivalent
K843160EMIT 700 COCAINE METABOLITE ASSAYDIOSubstantially Equivalent
K842673EMIT LOW & MEDIUM CALIBRATORS ASubstantially Equivalent
K842623MICROTRAK CHLAMYDIA TRACHOMATIS DIRECTLJPSubstantially Equivalent
K842390SYVA IQ 190 DIGITAL PIPETTER DILUTERJQWSubstantially Equivalent
K841238EMIT ST URINE CANNABINOID ASSAYLDJSubstantially Equivalent
K840939EMIT QST PRIMIDONE ASSAYDJDSubstantially Equivalent
K840400EMIT ST SERUM ETHYL ALCOHOL ASSAYDMLSubstantially Equivalent
K840193EMIT QST AMIKACIN ASSAYKLQSubstantially Equivalent
K840199EMIT ST SERUM PHENCYCLIDINE ASSAYLCMSubstantially Equivalent
K840164EMIT ST URINE METHAQUALONE ASSAYKXSSubstantially Equivalent
K840171EMIT ST URINE ETHYL ALCOHOL ASSAYDMLSubstantially Equivalent
K840061EMIT ST URINE PHENCYCLIDINE ASSAYLCMSubstantially Equivalent
K840060EMIT ST URINE METHADONE ASSAYDJRSubstantially Equivalent
K834550EMIT ST SERUM TRICYCLIC ANTIDEPRESSANTLFGSubstantially Equivalent
K834406EMIT QST PHENYTOIN ASSAYDIPSubstantially Equivalent
K833581MODIF. OF EMIT URINE OPIATE ASSAYDJGSubstantially Equivalent
K833580MODIF. OF EMIT URINE CANNABINOIDLDJSubstantially Equivalent
K833579MODIF. OF EMIT URINE AMPHETAMINEDKZSubstantially Equivalent
K833577MODIF. OF EMIT URINE BARBITURATEDISSubstantially Equivalent
K833959MICROLAB M DILUTER/DISPENSERJQWSubstantially Equivalent
K833791SYVA ADVANCE DIGOXIN ASSAYKXTSubstantially Equivalent
K833715EMIT NETILMICIN ASSAYLCESubstantially Equivalent
K833634EMIT & METHOFREXATE ASSAYLAOSubstantially Equivalent
K833623MODIF. OF EMIT CAD DISOPYRAMIDE ASSAYKLRSubstantially Equivalent
K833546MODIFICATION OF EMIT AND AMIKACIN ASSAYLDNSubstantially Equivalent
K832799MODIFICA- OF EMIT CAD LIDOCAINE ASSAYKLRSubstantially Equivalent
K832798MODIFICA-OF EMIT AED PRIMIDONE ASSAYDJDSubstantially Equivalent
K832720EMIT AED CARBAMAZEPINE ASSAYKLTSubstantially Equivalent
K832719EMIT AED VALPROIC ACID ASSAYLEGSubstantially Equivalent
K832797MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAYDLFSubstantially Equivalent
K832079COLLECTION KIT CHLAMYDIA TRACHOMATISLIOSubstantially 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