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

Hana Biologics, Inc. · Predicate Candidate Screening

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

85 daysmedian FDA review time
163 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K883682CHANG MEDIUM (ADDITIONAL INDICATIONS)Hana Biologics, Inc.1988-09-16180
K855205MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEMHana Biologics, Inc.1986-02-05370
K834616AMNIO STAT-FLM AGGLUTINATION TESTHana Biologics, Inc.1984-05-251630
K833933ACE COLOR TESTHana Biologics, Inc.1984-03-231300
K822737MYCOTRIUM-RSHana Biologics, Inc.1982-12-03850
K822736MYCOTRIUM-GUHana Biologics, Inc.1982-12-03850
K822150AMNISTAT-FLMHana Biologics, Inc.1982-10-21910
K812820CHANG MEDIUMHana Biologics, Inc.1981-11-10340

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