The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Sensititre Haemophilus/streptococcus Pneumoniae (hp) Mic Plates.
| Device ID | K040619 |
| 510k Number | K040619 |
| Device Name: | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
| Contact | Cynthia C Knapp |
| Correspondent | Cynthia C Knapp TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-09 |
| Decision Date | 2004-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05032384548606 | K040619 | 000 |