The following data is part of a premarket notification filed by Intracel Corp. with the FDA for Prima System - Old, Bartels Elisa - New.
| Device ID | K990664 |
| 510k Number | K990664 |
| Device Name: | PRIMA SYSTEM - OLD, BARTELS ELISA - NEW |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | INTRACEL CORP. 1330 PICCARD DR. Rockville, MD 20850 |
| Contact | Cecilia Matos-rosa |
| Correspondent | Cecilia Matos-rosa INTRACEL CORP. 1330 PICCARD DR. Rockville, MD 20850 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-01 |
| Decision Date | 1999-03-31 |
| Summary: | summary |