The following data is part of a premarket notification filed by Diamond Diagnostics, Inc. with the FDA for Standard A, Standard B, Standard C, Cal, Slope.
| Device ID | K013850 |
| 510k Number | K013850 |
| Device Name: | STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE |
| Classification | Calibrator, Secondary |
| Applicant | DIAMOND DIAGNOSTICS, INC. 331 FISKE ST. Holliston, MA 01746 |
| Contact | Linda M Stundtner |
| Correspondent | Linda M Stundtner DIAMOND DIAGNOSTICS, INC. 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 | 2001-11-20 |
| Decision Date | 2001-12-21 |
| Summary: | summary |