The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Aution Check Plus.
| Device ID | K142262 |
| 510k Number | K142262 |
| Device Name: | AUTION CHECK PLUS |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Contact | Kalyna Snylyk |
| Correspondent | Kalyna Snylyk QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-14 |
| Decision Date | 2015-04-10 |
| Summary: | summary |