The following data is part of a premarket notification filed by Blackhawk Biosystems, Inc. with the FDA for Virotrol Torch.
| Device ID | K942295 |
| 510k Number | K942295 |
| Device Name: | VIROTROL TORCH |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BLACKHAWK BIOSYSTEMS, INC. 12945 ALCOSTA BLVD. San Ramon, CA 94583 |
| Contact | Carole Polito |
| Correspondent | Carole Polito BLACKHAWK BIOSYSTEMS, INC. 12945 ALCOSTA BLVD. San Ramon, CA 94583 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-12 |
| Decision Date | 1994-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661002604 | K942295 | 000 |