# Microbiologics, Inc.

- Location (FDA's records): St. Cloud, MN
- FDA decisions: 18 (1995–2019): 18 510(k) clearances
- Product codes: PMN (8), JTO (7), JSP (3)
- 510(k) review time since 2016: median 57 days, against 71 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bio-Rad Laboratories, Inc.: 2 (https://510kreport.com/company/bio-rad-laboratories)

## Firms that cite its devices most
- Zeptometrix: 1 (https://510kreport.com/company/zeptometrix)

## Its most-cited devices
- K182472: Cepheid Xpert GBS LB Control Panel (2018), cited by 4
- K181683: BD MAX CT/GC/TV 20-Day QC Panel (2018), cited by 1

## Recent decisions
- K190086: Cepheid Xpert Respiratory Control Panel (Oct 7, 2019)
- K191168: Cepheid Xpert SA Nasal Complete Control Panel (Jun 25, 2019)
- K191172: Cepheid Xpert MRSA NxG Control Panel (Jun 20, 2019)
- K190223: Cepheid Xpert CT/NG Control Panel (May 8, 2019)
- K190463: Cepheid Xpert C. difficile/Epi Control Panel (Apr 19, 2019)
- K182472: Cepheid Xpert GBS LB Control Panel (Nov 8, 2018)
- K181683: BD MAX CT/GC/TV 20-Day QC Panel (Aug 28, 2018)
- K181711: BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel (Aug 15, 2018)

Source page: https://510kreport.com/company/microbiologics