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

Scott Laboratories, Inc. — Predicate Candidate Screening

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

32 daysmedian FDA review time
115 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K880694B. CAT CONFIRMScott Laboratories, Inc.1988-06-161150
K874933MUG-INDOLE DISCScott Laboratories, Inc.1988-01-05320
K874662MYCO-FLUOR REAGENT A & BScott Laboratories, Inc.1987-11-25120
K873509IDENTICULT-BLScott Laboratories, Inc.1987-10-15450
K871238ANABAGScott Laboratories, Inc.1987-04-0370
K863025SERO-STAT R II STAPHYLOCOCCUS TESTScott Laboratories, Inc.1986-09-15350
K852869SELECTICULT-CHLAMYDIAScott Laboratories, Inc.1985-09-19730
K852832IDENTICULT-NEISSERIAScott Laboratories, Inc.1985-07-19170
K852666IDENTICULT-AEScott Laboratories, Inc.1985-07-15210
K841680SCOTT SELECTICULT-HSV ISOLATION &Scott Laboratories, Inc.1984-10-301900
K811098SERO-STAT STAPHYLOCOCCUS TESTScott Laboratories, Inc.1981-05-05130
K790492SERO-STAT STREPTOCOCCUS TESTScott Laboratories, Inc.1979-05-01490
K780159ANASWABScott Laboratories, Inc.1978-02-13140
K771936MICROBIOLOGICAL CULTURE MEDIUMScott Laboratories, Inc.1977-12-06500
K770004P.R.A.S. CARY & BLAIR TRANSPORT MEDIUMScott Laboratories, Inc.1977-01-14110
K760598IMPROVED THAYER MARTIN MEDIUMScott Laboratories, Inc.1976-10-08310

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