The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Dri-stat Acid Phosphatase Reagent.
| Device ID | K053612 |
| 510k Number | K053612 |
| Device Name: | DRI-STAT ACID PHOSPHATASE REAGENT |
| Classification | Acid Phosphatase, Naphthyl Phosphate |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Eri Hirumi |
| Correspondent | Eri Hirumi BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | CKB |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-27 |
| Decision Date | 2006-04-26 |
| Summary: | summary |