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

Troy Biologicals, Inc. · Predicate Candidate Screening

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

34 daysmedian FDA review time
40 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K861301BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000Troy Biologicals, Inc.1986-04-21140
K832862TRANSGROW MEDIUMTroy Biologicals, Inc.1983-09-26340
K832861SABOURAUD DEXTROSE AGARTroy Biologicals, Inc.1983-09-26340
K832860SXT BLOOD AGARTroy Biologicals, Inc.1983-09-26340
K832863STREP ID QUADTroy Biologicals, Inc.1983-09-26340
K823310STREPTOCOCCUS SELECTIVE AGARTroy Biologicals, Inc.1982-12-15400
K823307CAMPYLOBACTER SELECTIVE AGARTroy Biologicals, Inc.1982-12-15400
K823306HEMOPHILUS QUAD 10 PLATETroy Biologicals, Inc.1982-12-15400
K823311COLUMBIA V AGAR W/5% HUMAN BLOODTroy Biologicals, Inc.1982-12-15400
K823308MYCAREL AGAR MYCOBROTIC AGARTroy Biologicals, Inc.1982-12-03280
K823309MARTIN & LEMIS AGAR W/VCAT INHIBITORTroy Biologicals, Inc.1982-12-03280
K810181DERMOTOPHYTE TEST MEDIUMTroy Biologicals, Inc.1981-02-05140

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