The following data is part of a premarket notification filed by Cooper Biomedical, Inc. with the FDA for Demand Acid Phosphatase Reagent.
| Device ID | K853949 |
| 510k Number | K853949 |
| Device Name: | DEMAND ACID PHOSPHATASE REAGENT |
| Classification | Acid Phosphatase, Naphthyl Phosphate |
| Applicant | COOPER BIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Contact | Carl Deaton |
| Correspondent | Carl Deaton COOPER BIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Product Code | CKB |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-24 |
| Decision Date | 1985-10-16 |