The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Bact/alert (tm).
| Device ID | K903505 |
| 510k Number | K903505 |
| Device Name: | BACT/ALERT (TM) |
| Classification | System, Blood Culturing |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Ann M Quinn |
| Correspondent | Ann M Quinn ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | MDB |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-03 |
| Decision Date | 1991-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026049591 | K903505 | 000 |
| 03573026049577 | K903505 | 000 |
| 03573026049522 | K903505 | 000 |
| 03573026047573 | K903505 | 000 |
| 03573026047566 | K903505 | 000 |
| 03573026535476 | K903505 | 000 |