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

Amedica Biotech, Inc. · Predicate Candidate Screening

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

84 daysmedian FDA review time
141 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K100108AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDAmedica Biotech, Inc.2010-04-14900
K082898AMEDICA DRUG SCREEN TEST CUPAmedica Biotech, Inc.2008-12-19800
K080872AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAAmedica Biotech, Inc.2008-08-191410
K063379AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR,Amedica Biotech, Inc.2006-12-11330
K061556AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; Amedica Biotech, Inc.2006-07-21460
K040464AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TESTAmedica Biotech, Inc.2004-05-17840
K031497AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TESTAmedica Biotech, Inc.2003-10-171570
K023101AMEDICA DRUG SCREEN METHAPHETAMINE TESTAmedica Biotech, Inc.2002-12-16890
K023104AMEDICA DRUG SCREEN AMPHETAMINE TESTAmedica Biotech, Inc.2002-12-16890
K023109AMEDICA DRUG SCREEN PHENCYCLIDINE TESTAmedica Biotech, Inc.2002-12-16890
K022955AMEDICA DRUG SCREEN THC TESTAmedica Biotech, Inc.2002-11-06620
K022954AMEDICA DRUG SCREEN COCAINE TESTAmedica Biotech, Inc.2002-11-06620
K023047AMEDICA DRUG SCREEN OPIATES TESTAmedica Biotech, Inc.2002-11-06550

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