The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Equate(tm) Aqr Apo Al/b Duo Control.
| Device ID | K903122 |
| 510k Number | K903122 |
| Device Name: | EQUATE(TM) AQR APO AL/B DUO CONTROL |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | BINAX, INC. 95 DARLING AVE. S. Portland, ME 04106 |
| Contact | David E Kelsey |
| Correspondent | David E Kelsey BINAX, INC. 95 DARLING AVE. S. Portland, ME 04106 |
| Product Code | DFC |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-16 |
| Decision Date | 1990-08-02 |