The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Synovialscopics, Synovial Fluid Control.
| Device ID | K010598 |
| 510k Number | K010598 |
| Device Name: | SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Contact | Eva Laszlo |
| Correspondent | Eva Laszlo QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-28 |
| Decision Date | 2001-03-23 |