The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus C3 Immunoturbidimetric Regent.
| Device ID | K962409 |
| 510k Number | K962409 |
| Device Name: | OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT |
| Classification | Complement C3, Antigen, Antiserum, Control |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | CZW |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-21 |
| Decision Date | 1996-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590010560 | K962409 | 000 |