The following data is part of a premarket notification filed by Tds Holdings Inc. with the FDA for Susceptibility Test Plate For Ertapenem 0.002-16ug/ml For Gram Negative. Susceptibility Test Plate For Ertapenem 0.015-.
| Device ID | K060621 |
| 510k Number | K060621 |
| Device Name: | SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015- |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | TDS HOLDINGS INC. 982 KEYNOTE CIRCLE, SUITE 6 Cleveland, OH 44131 |
| Contact | Cynthia C Knapp |
| Correspondent | Cynthia C Knapp TDS HOLDINGS 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 | 2006-03-08 |
| Decision Date | 2006-04-21 |