IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
FDA 510(k) clearance K071346 · decided 2007-09-24
Clearance details
- K-number
- K071346
- Device name
- IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
- Applicant
- Immco Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-05-14
- Decision date
- 2007-09-24
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- LIG
- Device class
- 2
- Regulation number
- 862.1810
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Buffalo, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Access Intrinsic Factor Ab (K240800) | Beckman Coulter, Inc. | 2024-05-03 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.