LIG
8 FDA 510(k) clearances · Product code
78 daysmedian time to decision
269 days90th percentile
8clearances measured
FDA profile
- Official device name
- Radioassay, Intrinsic Factor Blocking Antibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1810
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Access Intrinsic Factor Ab (K240800) | Beckman Coulter, Inc. | 2024-05-03 |
| IMMULISA INTRINSIC FACTOR ANTIBODY ELISA (K071346) | Immco Diagnostics, Inc. | 2007-09-24 |
| QUANTA LITE INTRINSIC FACTOR ELISA (K061841) | Inova Diagnostics, Inc. | 2006-12-22 |
| INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 (K033603) | Beckman Coulter, Inc. | 2003-12-19 |
| IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 (K993251) | Diagnostic Products Corp. | 1999-11-17 |
| ABBOTT ARCHITECT B12 (K984108) | Abbott Laboratories | 1999-02-03 |
| IMX B12 (K903218) | Abbott Laboratories | 1990-08-23 |
| 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY (K811927) | Corning Medical & Scientific | 1982-04-01 |
Track LIG automatically
Every clearance here is in the API, with alerts when new ones post.