The following data is part of a premarket notification filed by Wano-tech Corp. with the FDA for Prostatic Acid Phosphatase Reagent Test/prostatic Acid Phosphatase Reagent Kit.
| Device ID | K964756 |
| 510k Number | K964756 |
| Device Name: | PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT |
| Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
| Applicant | WANO-TECH CORP. 260 HARBOR BLVD. BELMONT, CA 94002 |
| Contact | K. PETER MOSSNER |
| Correspondent | K. PETER MOSSNER WANO-TECH CORP. 260 HARBOR BLVD. BELMONT, CA 94002 |
| Product Code | JFH |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-27 |
| Decision Date | 1997-04-23 |