The following data is part of a premarket notification filed by Miles Pharmaceuticals with the FDA for Cipro (tm) Diagnostic Powder.
| Device ID | K872081 |
| 510k Number | K872081 |
| Device Name: | CIPRO (TM) DIAGNOSTIC POWDER |
| Classification | Susceptibility Test Powders, Antimicrobial |
| Applicant | MILES PHARMACEUTICALS 400 MORGAN LN. West Haven, CT 06516 |
| Contact | Charles F Rayner |
| Correspondent | Charles F Rayner MILES PHARMACEUTICALS 400 MORGAN LN. West Haven, CT 06516 |
| Product Code | JTT |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-29 |
| Decision Date | 1987-06-15 |