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

Drug Screening Systems, Inc. · Predicate Candidate Screening

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

93 daysmedian FDA review time
331 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K945829MICROLINE SCREEN FOR BENZODIAZEPINEDrug Screening Systems, Inc.1995-01-25570
K935052MICROLINE SCREEN FOR AMPHETAMINEDrug Screening Systems, Inc.1994-09-163310
K933480MICROLINE SCREEN FOR BARBITURATESDrug Screening Systems, Inc.1993-10-291060
K921651MICROLINE SCREEN FOR PHENCYCLIDINEDrug Screening Systems, Inc.1992-07-08930
K914915MICROLINE SCREEN FOR CANNABINOIDDrug Screening Systems, Inc.1992-01-22790
K911652MIRCOLINE SCREEN FOR COCAINEDrug Screening Systems, Inc.1991-05-15330
K910525MICROLINE SCREEN FOR METHAMPHETAMINEDrug Screening Systems, Inc.1991-04-05570
K905491MICROLINE SCREEN FOR OPIATESDrug Screening Systems, Inc.1991-03-13960

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