The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for Aia-pack Bmg.
| Device ID | K900440 |
| 510k Number | K900440 |
| Device Name: | AIA-PACK BMG |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | TOSOH MEDICS, INC. COLUMBIA SQUARE 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein TOSOH MEDICS, INC. COLUMBIA SQUARE 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-29 |
| Decision Date | 1990-02-26 |