Atlas FDA

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

Bionetic Laboratory Products — Predicate Candidate Screening

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

77 daysmedian FDA review time
116 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K833637VZV BIO-ENZABEAD SCREEN KITBionetic Laboratory Products1984-02-101160
K832900IMMUNOENZYME TEST SYS-DETECT-IGM ANTIBionetic Laboratory Products1983-11-14770
K832069TOXO IPA KIT IAN INDIRECT FLUORESCENTBionetic Laboratory Products1983-09-26910
K831760LEGIONELLA IFA KIT IBionetic Laboratory Products1983-08-08680
K831133AMEBIASIS BIO-ENZABEAD SCREEN KITBionetic Laboratory Products1983-06-08620
K830820LEGIONELLA DFA KIT IBionetic Laboratory Products1983-06-08850
K830227AUTOMATED ELISA READER LBI 300Bionetic Laboratory Products1983-03-10450
K830405LBI-100 37DEGREES INCUBATORBionetic Laboratory Products1983-03-10310

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