The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Calcium Arsenazo Reagent, Osr60117, Osr61117, Osr65117.
| Device ID | K061575 |
| 510k Number | K061575 |
| Device Name: | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 |
| Classification | Azo Dye, Calcium |
| Applicant | OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Contact | Bev Harding |
| Correspondent | Bev Harding OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Product Code | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-07 |
| Decision Date | 2006-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590060183 | K061575 | 000 |
| 15099590011086 | K061575 | 000 |
| 15099590000325 | K061575 | 000 |