The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for Alkaline Phosphatase Test.
| Device ID | K862498 |
| 510k Number | K862498 |
| Device Name: | ALKALINE PHOSPHATASE TEST |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
| Contact | Frances K Loh |
| Correspondent | Frances K Loh KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-01 |
| Decision Date | 1986-09-26 |