The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Acid Phosphatase Procedure.
| Device ID | K842516 |
| 510k Number | K842516 |
| Device Name: | SANDARE ACID PHOSPHATASE PROCEDURE |
| Classification | Acid Phosphatase, Thymol Blue Monophosphate |
| Applicant | SANDARE CHEMICAL CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CJR |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-10 |
| Decision Date | 1984-08-17 |