The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Ena 6 Elisa.
Device ID | K961913 |
510k Number | K961913 |
Device Name: | QUANTA LITE ENA 6 ELISA |
Classification | Extractable Antinuclear Antibody, Antigen And Control |
Applicant | INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. San Diego, CA 92121 |
Contact | Brys C Myers |
Correspondent | Brys C Myers INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. San Diego, CA 92121 |
Product Code | LLL |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-17 |
Decision Date | 1996-07-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08426950455127 | K961913 | 000 |