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

Bioclinical Systems, Inc. — Predicate Candidate Screening

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

82 daysmedian FDA review time
223 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K950196CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIABioclinical Systems, Inc.1995-06-301630
K945911CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HIBioclinical Systems, Inc.1995-04-041230
K933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGARBioclinical Systems, Inc.1994-02-092290
K933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGARBioclinical Systems, Inc.1994-02-032230
K873086ROUND 1Bioclinical Systems, Inc.1987-08-24180
K860334VISI-CHECK HLH TEST MONOCLONALBioclinical Systems, Inc.1986-04-21820
K860333MICRO-ELISA HLH TEST KIT MONOCLONALBioclinical Systems, Inc.1986-04-21820
K855227MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONALBioclinical Systems, Inc.1986-04-111020
K854059MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NOBioclinical Systems, Inc.1986-01-131020
K854379MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KITBioclinical Systems, Inc.1986-01-07690
K850079NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCGBioclinical Systems, Inc.1985-03-05540
K850257BCS GLUCOSE COLORIMETRIC TESTBioclinical Systems, Inc.1985-03-05420
K850258BCS POTASSIUM TURBIDIMETRIC TESTBioclinical Systems, Inc.1985-02-07160

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