Atlas FDA

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

Pan Probe Biotech, Inc. — Predicate Candidate Screening

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

14 daysmedian FDA review time
111 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K020968LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARDPan Probe Biotech, Inc.2002-07-151110
K013796LIVESURE METHADONE SCREEN TESTSPan Probe Biotech, Inc.2001-11-26110
K012107LIVESURE PHENECYCLINE (PCP) SCREEN TESTSPan Probe Biotech, Inc.2001-07-20150
K012133LIVESURE BARBITURATES SCREEN TESTPan Probe Biotech, Inc.2001-07-20110
K012131LIVESURE BENZODIAZEPINES SCREEN TESTSPan Probe Biotech, Inc.2001-07-20110
K011609LIVESURE AMPHETAMINE SCREEN TESTPan Probe Biotech, Inc.2001-06-08140
K011610LIVESURE METHAMPHETAMINE SCREEN TESTSPan Probe Biotech, Inc.2001-06-08140
K010967LIVESURE COCAINE SCREEN TESTPan Probe Biotech, Inc.2001-04-17150
K011011LIVESURE MORPHINE SCREEN TESTPan Probe Biotech, Inc.2001-04-1390
K010001LIVESURE THC SCREEN TESTPan Probe Biotech, Inc.2001-02-05340

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