The following data is part of a premarket notification filed by Allied Instrumentation Laboratory with the FDA for Multi-4 Co-oximeter Control.
| Device ID | K861901 |
| 510k Number | K861901 |
| Device Name: | MULTI-4 CO-OXIMETER CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ALLIED INSTRUMENTATION LABORATORY 113 HARTWELL AVE. Lexington, MA 02173 |
| Contact | George Lyna |
| Correspondent | George Lyna ALLIED INSTRUMENTATION LABORATORY 113 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-16 |
| Decision Date | 1986-06-17 |