The following data is part of a premarket notification filed by Crestat Diagnostics, Inc. with the FDA for Acid Phosphotase Reagent Test And Kit.
| Device ID | K902543 |
| 510k Number | K902543 |
| Device Name: | ACID PHOSPHOTASE REAGENT TEST AND KIT |
| Classification | Acid Phosphatase, Naphthyl Phosphate |
| Applicant | CRESTAT DIAGNOSTICS, INC. P.O. BOX 18225 Portland, OR 97218 |
| Contact | Keltner, M.d. |
| Correspondent | Keltner, M.d. CRESTAT DIAGNOSTICS, INC. P.O. BOX 18225 Portland, OR 97218 |
| Product Code | CKB |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-06 |
| Decision Date | 1990-09-07 |