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

Toledo, OH, US

Advanced Clinical Diagnostics appears in FDA device records in Toledo, OH. FDA records list 19 510(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
19
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 19 510(k) clearances for Advanced Clinical Diagnostics between 1988 and 1994. The busiest year on record is 1994, with 18. The most recent is 1994, with 18.

Clearances by year, as a table
510(k) clearance decisions for Advanced Clinical Diagnostics, by decision year
YearClearances
19881
199418
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K936172RHESUS MONKEY KIDNEY CELLS (LLC-MK2)KIRSubstantially Equivalent
K936171TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEYKIRSubstantially Equivalent
K936169RHESUS MONKEY KIDNEY CELLSKIRSubstantially Equivalent
K934973HELA-229/HELA CELLSKIRSubstantially Equivalent
K934934RABBIT KIDNEY CELLS - R.K.C.KIRSubstantially Equivalent
K935766PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLSKIRSubstantially Equivalent
K935339HELA HELA EPITHELOID CARCINOMAKIRSubstantially Equivalent
K935338LUNG CACINOMA, HUMAN CELLSKIRSubstantially Equivalent
K935337RHABDOMYOSARCOMA CELLSKIRSubstantially Equivalent
K935336CYNOMOLOGUS MONKEY KIDNEY CELLSKIRSubstantially Equivalent
K934246LUNG DIPLOID HUMAN CELLS-WI-38KIRSubstantially Equivalent
K934245HUMAN FORESKIN FIBROBLAST CELLS-H.F.F.KIRSubstantially Equivalent
K934244HUMAN LUNG DIPLOID CELLS-MRC-5KIRSubstantially Equivalent
K934243HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2KIRSubstantially Equivalent
K934242BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.KIRSubstantially Equivalent
K934241MCCOY CULTURE CELLS-MCCOYKIRSubstantially Equivalent
K934240KIDNEY AFRICIAN GREEN MONKEY CELLS-VEROKIRSubstantially Equivalent
K934239KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1KIRSubstantially Equivalent
K883560CDT CYTOTOXI TESTLLHSubstantially 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