Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microbiologics, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
184 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190086 | Cepheid Xpert Respiratory Control Panel | Microbiologics, Inc. | 2019-10-07 | 263 | 0 |
| K191168 | Cepheid Xpert SA Nasal Complete Control Panel | Microbiologics, Inc. | 2019-06-25 | 55 | 0 |
| K191172 | Cepheid Xpert MRSA NxG Control Panel | Microbiologics, Inc. | 2019-06-20 | 50 | 0 |
| K190223 | Cepheid Xpert CT/NG Control Panel | Microbiologics, Inc. | 2019-05-08 | 92 | 0 |
| K190463 | Cepheid Xpert C. difficile/Epi Control Panel | Microbiologics, Inc. | 2019-04-19 | 52 | 0 |
| K182472 | Cepheid Xpert GBS LB Control Panel | Microbiologics, Inc. | 2018-11-08 | 59 | 0 |
| K181683 | BD MAX CT/GC/TV 20-Day QC Panel | Microbiologics, Inc. | 2018-08-28 | 63 | 0 |
| K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasi | Microbiologics, Inc. | 2018-08-15 | 48 | 0 |
| K970009 | LYFO(TM) DIFFERENTIAL DISK-BACITRACIN | Microbiologics, Inc. | 1997-02-06 | 35 | 0 |
| K954812 | LYFO(TM) DIFFERIENTAL DISK-PYR | Microbiologics, Inc. | 1995-12-20 | 62 | 0 |
| K951889 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-08-24 | 122 | 0 |
| K945488 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-05-11 | 184 | 0 |
| K945489 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-05-11 | 184 | 0 |
| K945487 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-05-11 | 184 | 0 |
| K945883 | LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN | Microbiologics, Inc. | 1995-04-24 | 144 | 0 |
| K945882 | LYFO(TM) DIFFERENTIAL DISK-BILE | Microbiologics, Inc. | 1995-04-24 | 144 | 0 |
| K945880 | LYFO(TM) DIFFERENTIAL DISK-SPS | Microbiologics, Inc. | 1995-04-24 | 144 | 0 |
| K945881 | LYFO(TM) DIFFERENTIAL DISK-STERILE DISK | Microbiologics, Inc. | 1995-04-24 | 144 | 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