The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Uric Acid Test Item Number 65422.
Device ID | K932162 |
510k Number | K932162 |
Device Name: | URIC ACID TEST ITEM NUMBER 65422 |
Classification | Acid, Uric, Uricase (u.v.) |
Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
Contact | Carol Faulkner |
Correspondent | Carol Faulkner EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
Product Code | CDO |
CFR Regulation Number | 862.1775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-04 |
Decision Date | 1993-09-27 |