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

Microline Scientific — Predicate Candidate Screening

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

38 daysmedian FDA review time
44 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K841844DIFFERENTIAL CULTURE MEDIUM-BIGGY AGARMicroline Scientific1984-05-31440
K841843DIFFERENTIAL CULTURE MED. LEVINE EMBMicroline Scientific1984-05-31440
K841586CHOCOLATE AGARMicroline Scientific1984-05-31440
K841842DIFFERENTIAL CULTURE MED. MACCONKEY AGARMicroline Scientific1984-05-31440
K841845SELECTIVE CULTURE MED. COLUMBIA CNAMicroline Scientific1984-05-31440
K841840SELECTIVE CULTURE MED. PHENYLETHYL ALCOMicroline Scientific1984-05-25380
K841841DIFFERENTIAL CULTURE MED. MANNITOL SALTMicroline Scientific1984-05-25380
K841839SELECTIVE CULTURE MED. SELECTIVE STREPMicroline Scientific1984-05-25380
K841838ENRICHED CULTURE MED. TRYPTIC SOY AGARMicroline Scientific1984-05-21340
K841837ENRICHED CULTURE MED. FLUID THIOGLYC0Microline Scientific1984-05-21340
K841834CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEPMicroline Scientific1984-05-14270
K841833CULTURE MEDIUM FOR PATHOGENIC NEISSERMicroline Scientific1984-05-14270
K841836SELECTIVE CULTURE MED. TRICHOMONASMicroline Scientific1984-05-14270
K841835MULTIPURPOSE CULTURE MEDIUMMicroline Scientific1984-05-14270

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