Atlas FDA

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

Microbix Biosystems, Inc. — Predicate Candidate Screening

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

126 daysmedian FDA review time
126 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K894261TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGENMicrobix Biosystems, Inc.1989-10-161170
K894262RUBELLA ANTIGEN AND CONTROL ANTIGENMicrobix Biosystems, Inc.1989-10-161170
K852929CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTRMicrobix Biosystems, Inc.1985-11-121260
K852931HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLTMicrobix Biosystems, Inc.1985-11-121260
K852932MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLTMicrobix Biosystems, Inc.1985-11-121260
K852930VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTROMicrobix Biosystems, Inc.1985-11-121260
K852933MYCOPLASMA SPP SEROLOGICAL REAGENTSMicrobix Biosystems, Inc.1985-08-01230

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