The following data is part of a premarket notification filed by Mission Diagnostics with the FDA for Calibrating Material, Buffers, Standard.
| Device ID | K022027 |
| 510k Number | K022027 |
| Device Name: | CALIBRATING MATERIAL, BUFFERS, STANDARD |
| Classification | Calibrator, Secondary |
| Applicant | MISSION DIAGNOSTICS 331 FISKE ST. Holliston, MA 01746 |
| Contact | Linda Stundtner |
| Correspondent | Linda Stundtner MISSION DIAGNOSTICS 331 FISKE ST. Holliston, MA 01746 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-21 |
| Decision Date | 2002-07-22 |
| Summary: | summary |