Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Advanced Clinical Diagnostics — Predicate Candidate Screening

19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

102 daysmedian FDA review time
130 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K936172RHESUS MONKEY KIDNEY CELLS (LLC-MK2)Advanced Clinical Diagnostics1994-02-03420
K936169RHESUS MONKEY KIDNEY CELLSAdvanced Clinical Diagnostics1994-02-03420
K936171TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEYAdvanced Clinical Diagnostics1994-02-03420
K934973HELA-229/HELA CELLSAdvanced Clinical Diagnostics1994-01-281020
K934934RABBIT KIDNEY CELLS - R.K.C.Advanced Clinical Diagnostics1994-01-281550
K935766PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLSAdvanced Clinical Diagnostics1994-01-24800
K935337RHABDOMYOSARCOMA CELLSAdvanced Clinical Diagnostics1994-01-03590
K935339HELA HELA EPITHELOID CARCINOMAAdvanced Clinical Diagnostics1994-01-03590
K934244HUMAN LUNG DIPLOID CELLS-MRC-5Advanced Clinical Diagnostics1994-01-031300
K934245HUMAN FORESKIN FIBROBLAST CELLS-H.F.F.Advanced Clinical Diagnostics1994-01-031300
K934240KIDNEY AFRICIAN GREEN MONKEY CELLS-VEROAdvanced Clinical Diagnostics1994-01-031300
K934246LUNG DIPLOID HUMAN CELLS-WI-38Advanced Clinical Diagnostics1994-01-031300
K935338LUNG CACINOMA, HUMAN CELLSAdvanced Clinical Diagnostics1994-01-03590
K934242BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.Advanced Clinical Diagnostics1994-01-031300
K934239KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1Advanced Clinical Diagnostics1994-01-031300
K934243HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2Advanced Clinical Diagnostics1994-01-031300
K934241MCCOY CULTURE CELLS-MCCOYAdvanced Clinical Diagnostics1994-01-031300
K935336CYNOMOLOGUS MONKEY KIDNEY CELLSAdvanced Clinical Diagnostics1994-01-03590
K883560CDT CYTOTOXI TESTAdvanced Clinical Diagnostics1988-10-25670

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda