# Biotrol, USA, Inc.

- Location (FDA's records): Malvern, PA
- FDA decisions: 46 (1987–1995): 46 510(k) clearances
- Product codes: JIX (5), JJY (4), JIR (2), LGD (2), CDT (2), CIJ (2), JGJ (2), JIS (2), CJY (1), CGA (1), CKA (1), JHX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K934014: Vacusol Plus Dental Vacuum Line Cleaner/Disinfectant (Dec 6, 1995)
- K931141: Biotrol Amylase CNPG3 (May 26, 1993)
- K921855: Biotrol Bicarbonate Standards (Aug 3, 1992)
- K921677: Biotrol Magnesium (Magon) (May 26, 1992)
- K912795: Biotrol Uibc Reagent (Aug 12, 1991)
- K910721: Biotrol Protein Multilevel Standards (May 6, 1991)
- K905683: Biotrol Lactate Dehydrogenase (L-P) (Mar 11, 1991)
- K905280: Biotrol Bilirubin C & T Control (Feb 4, 1991)

Source page: https://510kreport.com/company/biotrol-usa