The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Chromatin Elisa.
Device ID | K982603 |
510k Number | K982603 |
Device Name: | QUANTA LITE CHROMATIN ELISA |
Classification | Extractable Antinuclear Antibody, Antigen And Control |
Applicant | INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
Contact | Brys C Myers |
Correspondent | Brys C Myers INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
Product Code | LLL |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-27 |
Decision Date | 1998-10-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08426950506355 | K982603 | 000 |