SPINALSCOPICS
Multi-analyte Controls, All Kinds (assayed)
QUANTIMETRIX CORP.
The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Spinalscopics.
Pre-market Notification Details
| 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 |
Trademark Results [SPINALSCOPICS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPINALSCOPICS 76028641 2514498 Live/Registered |
Quantimetrix Corporation 2000-04-18 |
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