Atlas FDA

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

Scripps-Miles, Inc. — Predicate Candidate Screening

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

25 daysmedian FDA review time
43 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K812453SCRIPPSYSTEM IMMUNOGLOBIN RID KITScripps-Miles, Inc.1981-09-23260
K812328SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KITScripps-Miles, Inc.1981-09-08210
K811714HEP-2-CRITHIDIA LUCILIAE ANA TEST KITScripps-Miles, Inc.1981-07-10230
K811433SCRIPPSERA COMPLEMENT CONTROL SERAScripps-Miles, Inc.1981-06-16250
K810501SCRIPPSYSTEM C3 RID KITScripps-Miles, Inc.1981-04-08430
K810502SCRIPPSYSTEM C4 RID KITScripps-Miles, Inc.1981-04-08430
K810081SCRIPPSERA ANA REFERENCE CONTROL SERAScripps-Miles, Inc.1981-02-09270
K810221SCRIPPSERA THEUMATOID FACTOR REFER. CNTLScripps-Miles, Inc.1981-02-09130
K810141SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KITScripps-Miles, Inc.1981-02-09190

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