The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Thb Cal Standard For Il Co-oximeters/oximeters.
| Device ID | K962864 |
| 510k Number | K962864 |
| Device Name: | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS |
| Classification | Calibrator For Hemoglobin And Hematocrit Measurement |
| Applicant | ALKO DIAGNOSTIC CORP. 333 FISKE ST. Holliston, MA 01746 |
| Contact | Janet A Mcgrath |
| Correspondent | Janet A Mcgrath 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 | 1996-07-23 |
| Decision Date | 1996-12-18 |
| Summary: | summary |