The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Heamophilus/streptococcus Pneumoniae.
| Device ID | K012895 |
| 510k Number | K012895 |
| Device Name: | HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | TREK DIAGNOSTIC SYSTEMS, INC. 29299 CLEMENS RD., SUITE 1-K Westlake, OH 44145 |
| Contact | Cynthia C Kapp |
| Correspondent | Cynthia C Kapp TREK DIAGNOSTIC SYSTEMS, INC. 29299 CLEMENS RD., SUITE 1-K Westlake, OH 44145 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-28 |
| Decision Date | 2001-10-30 |