The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Cardiasure Cardiac Markers Control.
| Device ID | K993723 |
| 510k Number | K993723 |
| Device Name: | CARDIASURE CARDIAC MARKERS CONTROL |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Contact | Evy K Johnson |
| Correspondent | Evy K Johnson QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-03 |
| Decision Date | 1999-11-23 |
| Summary: | summary |