The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Quantimetrix Blood Glucose Controls.
| Device ID | K932623 |
| 510k Number | K932623 |
| Device Name: | QUANTIMETRIX BLOOD GLUCOSE CONTROLS |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | QUANTIMETRIX CORP. 4955 WEST 145 ST. Hawthorne, CA 90250 -6703 |
| Contact | John P Tarburton |
| Correspondent | John P Tarburton QUANTIMETRIX CORP. 4955 WEST 145 ST. Hawthorne, CA 90250 -6703 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-01 |
| Decision Date | 1993-12-09 |