The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Preciset Dat Plus.
| Device ID | K021393 |
| 510k Number | K021393 |
| Device Name: | PRECISET DAT PLUS |
| Classification | Calibrators, Drug Mixture |
| Applicant | QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Contact | Gebhard Neyer |
| Correspondent | Gebhard Neyer QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-02 |
| Decision Date | 2002-06-13 |
| Summary: | summary |