The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Alko Tonometered Saline Control.
| Device ID | K950902 |
| 510k Number | K950902 |
| Device Name: | ALKO TONOMETERED SALINE CONTROL |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | ALKO DIAGNOSTIC CORP. 333 FISKE ST. Holliston, MA 01746 |
| Contact | Brian J Young |
| Correspondent | Brian J Young ALKO DIAGNOSTIC CORP. 333 FISKE ST. Holliston, MA 01746 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-28 |
| Decision Date | 1995-03-30 |