The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for Acid Phosphatase Test.
Device ID | K873726 |
510k Number | K873726 |
Device Name: | ACID PHOSPHATASE TEST |
Classification | Acid Phosphatase, Thymolphthale Inmonophosphate |
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 | CKE |
CFR Regulation Number | 862.1020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-15 |
Decision Date | 1988-01-27 |