The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Cholinesterase Reagent (catalog Number Osr6114).
| Device ID | K030045 |
| 510k Number | K030045 |
| Device Name: | OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) |
| Classification | Colorimetry, Cholinesterase |
| Applicant | OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Contact | Michael Campbell |
| Correspondent | Michael Campbell OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Product Code | DIH |
| CFR Regulation Number | 862.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-06 |
| Decision Date | 2003-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590010133 | K030045 | 000 |