Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LIG · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
269 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240800 | Access Intrinsic Factor Ab | Beckman Coulter, Inc. | 2024-05-03 | 39 | 0 |
| K071346 | IMMULISA INTRINSIC FACTOR ANTIBODY ELISA | Immco Diagnostics, Inc. | 2007-09-24 | 133 | 0 |
| K061841 | QUANTA LITE INTRINSIC FACTOR ELISA | Inova Diagnostics, Inc. | 2006-12-22 | 176 | 0 |
| K033603 | INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMU | Beckman Coulter, Inc. | 2003-12-19 | 32 | 0 |
| K993251 | IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 | Diagnostic Products Corp. | 1999-11-17 | 50 | 1 |
| K984108 | ABBOTT ARCHITECT B12 | Abbott Laboratories | 1999-02-03 | 78 | 3 |
| K903218 | IMX B12 | Abbott Laboratories | 1990-08-23 | 31 | 0 |
| K811927 | 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY | Corning Medical & Scientific | 1982-04-01 | 269 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda