The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Quantimetrix C-clear(tm).
| Device ID | K931523 |
| 510k Number | K931523 |
| Device Name: | QUANTIMETRIX C-CLEAR(TM) |
| Classification | Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric) |
| Applicant | QUANTIMETRIX CORP. 4955 WEST 145 ST. Hawthorne, CA 90250 -6703 |
| Contact | Himawan Sutisna |
| Correspondent | Himawan Sutisna QUANTIMETRIX CORP. 4955 WEST 145 ST. Hawthorne, CA 90250 -6703 |
| Product Code | JMA |
| CFR Regulation Number | 862.1095 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-26 |
| Decision Date | 1993-06-25 |