The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Gemeni Uric Acid U.v..
Device ID | K873358 |
510k Number | K873358 |
Device Name: | GEMENI URIC ACID U.V. |
Classification | Acid, Uric, Uricase (u.v.) |
Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
Contact | Labrec, Phd |
Correspondent | Labrec, Phd ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
Product Code | CDO |
CFR Regulation Number | 862.1775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-21 |
Decision Date | 1987-09-11 |