The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Test Acid Phosphatase.
| Device ID | K943366 |
| 510k Number | K943366 |
| Device Name: | IL TEST ACID PHOSPHATASE |
| Classification | Acid Phosphatase, Naphthyl Phosphate |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Wallis W Cady |
| Correspondent | Wallis W Cady INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | CKB |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-13 |
| Decision Date | 1996-01-29 |