The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Bilirubin Monoreactif.
| Device ID | K884480 |
| 510k Number | K884480 |
| Device Name: | BIOTROL BILIRUBIN MONOREACTIF |
| Classification | Cresolphthalein Complexone, Calcium |
| Applicant | BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester, PA 19380 |
| Contact | Allan C Murphy |
| Correspondent | Allan C Murphy BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester, PA 19380 |
| Product Code | CIC |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-25 |
| Decision Date | 1988-11-29 |