The following data is part of a premarket notification filed by Intracel Corp. with the FDA for Bartels Viral Respiratory Screening And Identification Kit.
| Device ID | K003204 |
| 510k Number | K003204 |
| Device Name: | BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT |
| Classification | Antisera, Cf, Influenza Virus A, B, C |
| Applicant | INTRACEL CORP. 1330 PICCARD DR. Rockville, MD 20850 |
| Contact | Shane Ward |
| Correspondent | Shane Ward INTRACEL CORP. 1330 PICCARD DR. Rockville, MD 20850 |
| Product Code | GNW |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-13 |
| Decision Date | 2000-11-07 |