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

Micro-Bio-Logics — Predicate Candidate Screening

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

19 daysmedian FDA review time

112 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K870731	LYFO KWIK(TM) RUS KIT	Micro-Bio-Logics	1987-06-17	112	0
K861312	LYFO-KWIK (TM) COAGULASE PLASMA	Micro-Bio-Logics	1986-04-18	10	0
K861022	KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS	Micro-Bio-Logics	1986-04-04	17	18
K855172	KWI (TM) G-CO/TWO	Micro-Bio-Logics	1986-02-20	56	0
K855198	INDI KWIK (TM) CO/TWO KIT	Micro-Bio-Logics	1986-01-14	18	0
K852998	NEISSERIA - KWIK PLUS	Micro-Bio-Logics	1985-07-23	8	0
K851978	LYFO-KWIK OMI KIT	Micro-Bio-Logics	1985-06-04	28	0
K844014	ONO/CO-TWO (TM) SYSTEMS	Micro-Bio-Logics	1984-10-31	19	0
K842129	LYFO-DISK MICROORGANISMS	Micro-Bio-Logics	1984-07-03	35	0

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