The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Spinalscopics.
Device ID | K970862 |
510k Number | K970862 |
Device Name: | SPINALSCOPICS |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
Contact | Evy Johnson |
Correspondent | Evy Johnson QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-03-07 |
Decision Date | 1997-04-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SPINALSCOPICS 76028641 2514498 Live/Registered |
Quantimetrix Corporation 2000-04-18 |