The following data is part of a premarket notification filed by Dade Microscan, Inc. with the FDA for Streptococcus Mic Panel.
| Device ID | K963641 |
| 510k Number | K963641 |
| Device Name: | STREPTOCOCCUS MIC PANEL |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | DADE MICROSCAN, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Sharolyn J Lentsch |
| Correspondent | Sharolyn J Lentsch DADE MICROSCAN, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-12 |
| Decision Date | 1996-12-18 |