FDA Product Code
FDA Product Code LIG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1810
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240800 | Access Intrinsic Factor Ab | Beckman Coulter, Inc. | 2024-05-03 | Traditional | PDF ↗ |
| K071346 | IMMULISA INTRINSIC FACTOR ANTIBODY ELISA | Immco Diagnostics, Inc. | 2007-09-24 | Traditional | PDF ↗ |
| K061841 | QUANTA LITE INTRINSIC FACTOR ELISA | Inova Diagnostics, Inc. | 2006-12-22 | Traditional | PDF ↗ |
| K033603 | INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 | Beckman Coulter, Inc. | 2003-12-19 | Traditional | PDF ↗ |
| K993251 | IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 | Diagnostic Products Corp. | 1999-11-17 | Traditional | PDF ↗ |
| K984108 | ABBOTT ARCHITECT B12 | Abbott Laboratories | 1999-02-03 | Traditional | PDF ↗ |
| K903218 | IMX B12 | Abbott Laboratories | 1990-08-23 | Traditional | PDF ↗ |
| K811927 | 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY | Corning Medical & Scientific | 1982-04-01 | Traditional | PDF ↗ |
Product code LIG · Class II · Clinical Chemistry. Data: openFDA.