The following data is part of a premarket notification filed by Miles, Inc. with the FDA for Folate Assay For The Technicon Immuno 1 System, In Vitro Diagnostic System.
| Device ID | K950292 |
| 510k Number | K950292 |
| Device Name: | FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | MILES, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca, Jr. |
| Correspondent | Gabriel J Muraca, Jr. MILES, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | CGN |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-25 |
| Decision Date | 1995-05-02 |