The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Virgo(tm) Rubella Igg Elisa.
Device ID | K873088 |
510k Number | K873088 |
Device Name: | VIRGO(TM) RUBELLA IGG ELISA |
Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
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 | LFX |
CFR Regulation Number | 866.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-05 |
Decision Date | 1987-09-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05391516747004 | K873088 | 000 |
05391516743433 | K873088 | 000 |
05391516746786 | K873088 | 000 |
05391516746748 | K873088 | 000 |
05391516746878 | K873088 | 000 |
05391516746533 | K873088 | 000 |
05391516746526 | K873088 | 000 |
05391516746519 | K873088 | 000 |