The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Alko Slope Thb Solution For Corning 280, 288 And 2500 Analyzers.
| Device ID | K951071 |
| 510k Number | K951071 |
| Device Name: | ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS |
| Classification | Calibrator For Hemoglobin And Hematocrit Measurement |
| 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 | KRZ |
| CFR Regulation Number | 864.8165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-08 |
| Decision Date | 1995-07-24 |