The following data is part of a premarket notification filed by Intracel Corp. with the FDA for Bartels Legionella Urinary Antigen Elisa Test.
| Device ID | K991074 |
| 510k Number | K991074 |
| Device Name: | BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST |
| Classification | Legionella, Spp., Elisa |
| Applicant | INTRACEL CORP. 1330 PICCARD DR. Rockville, MD 20850 |
| Contact | Sheryl Ruppel |
| Correspondent | Sheryl Ruppel INTRACEL CORP. 1330 PICCARD DR. Rockville, MD 20850 |
| Product Code | MJH |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-31 |
| Decision Date | 1999-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516744065 | K991074 | 000 |
| 05391516746670 | K991074 | 000 |