The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Gemstar Ii System.
Device ID | K873617 |
510k Number | K873617 |
Device Name: | GEMSTAR II SYSTEM |
Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
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 | JJE |
CFR Regulation Number | 862.2160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-08 |
Decision Date | 1987-10-19 |