The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Ph Blood Gas Control Products.
| Device ID | K884266 |
| 510k Number | K884266 |
| Device Name: | PH BLOOD GAS CONTROL PRODUCTS |
| Classification | Mixture, Hematology Quality Control |
| Applicant | ALKO DIAGNOSTIC CORP. ALKO PARK 333 FISKE ST. Holliston, MA 01746 |
| Contact | J Kovacs |
| Correspondent | J Kovacs ALKO DIAGNOSTIC CORP. ALKO PARK 333 FISKE ST. Holliston, MA 01746 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-11 |
| Decision Date | 1989-05-16 |