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

Ncs Diagnostics, Inc. — Predicate Candidate Screening

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

26 daysmedian FDA review time
170 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K943499KULTSURE STARSWAB(M240), MODIFICATIONNcs Diagnostics, Inc.1994-11-301700
K943498KULTSURE STARSWAB (M210), MODIFICATIONNcs Diagnostics, Inc.1994-11-301700
K882811STREPSLIDENcs Diagnostics, Inc.1988-10-251100
K881209ASO SLIDE TESTNcs Diagnostics, Inc.1988-04-12220
K874019STAPHSLIDENcs Diagnostics, Inc.1987-10-28260
K871404KULTSURENcs Diagnostics, Inc.1987-04-21130
K870231KULTSURENcs Diagnostics, Inc.1987-02-04140
K860178KULTSURE (CULTURE TRANSPORT)Ncs Diagnostics, Inc.1986-04-04770
K860655KULTSURE (CATALOGUE NO. M200)Ncs Diagnostics, Inc.1986-03-06130
K860657KULTSURE (CATALOGUE NO. M240)Ncs Diagnostics, Inc.1986-03-04110
K860656KULTSURE (CATALOGUE NO. M210)Ncs Diagnostics, Inc.1986-03-04110
K860658KULTSURE (CATALOGUE NO. M250)Ncs Diagnostics, Inc.1986-03-04110
K851504VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010Ncs Diagnostics, Inc.1985-08-191260
K851506SERUM TRANSPORT VIALS, T25/SC, TZ10/SCNcs Diagnostics, Inc.1985-06-27730
K841146NCS RA LATEX TESTNcs Diagnostics, Inc.1984-04-20350

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