The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Intrinsic Factor Elisa.
| Device ID | K061841 |
| 510k Number | K061841 |
| Device Name: | QUANTA LITE INTRINSIC FACTOR ELISA |
| Classification | Radioassay, Intrinsic Factor Blocking Antibody |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Contact | Gary L Norman |
| Correspondent | Gary L Norman INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Product Code | LIG |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-29 |
| Decision Date | 2006-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950454526 | K061841 | 000 |