The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for B-2-microglobulin Immunological Test System.
| Device ID | K991136 |
| 510k Number | K991136 |
| Device Name: | B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| 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 | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-05 |
| Decision Date | 1999-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590010485 | K991136 | 000 |