The following data is part of a premarket notification filed by Allied Instrumentation Laboratory with the FDA for Il System 1304 & 1306, Ph/blood Gas Analyzers.
| Device ID | K852676 |
| 510k Number | K852676 |
| Device Name: | IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | ALLIED INSTRUMENTATION LABORATORY 113 HARTWELL AVE. Lexington, MA 02173 |
| Contact | George A Lyna |
| Correspondent | George A Lyna ALLIED INSTRUMENTATION LABORATORY 113 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-24 |
| Decision Date | 1985-07-22 |