The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Naphthyl Phosphate, Acid Phosphatase.
| Device ID | K863832 |
| 510k Number | K863832 |
| Device Name: | NAPHTHYL PHOSPHATE, ACID PHOSPHATASE |
| Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
| Applicant | POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224 |
| Contact | William F Walters |
| Correspondent | William F Walters POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224 |
| Product Code | JFH |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-30 |
| Decision Date | 1986-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727012210 | K863832 | 000 |
| 00811727010001 | K863832 | 000 |