510(k) K033603
- Device
- INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999
- Applicant
- BECKMAN COULTER, INC.
- 510(k) number
- K033603
- Product code
- LIG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-12-19
- Date received
- 2003-11-17
- Regulation
- 862.1810
- Classification name
- Radioassay, Intrinsic Factor Blocking Antibody
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VALYNDA MACHEN
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 2026994
- 3009518015
- 3002806944
- 2122870
- 2432235
Source Documents#
Other 510(k) Records For Product Code LIG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240800 | Access Intrinsic Factor Ab | Beckman Coulter, Inc. | 2024-05-03 |
| K071346 | IMMULISA INTRINSIC FACTOR ANTIBODY ELISA | Immco Diagnostics, Inc. | 2007-09-24 |
| K061841 | QUANTA LITE INTRINSIC FACTOR ELISA | Inova Diagnostics, Inc. | 2006-12-22 |
| K993251 | IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 | Diagnostic Products Corp. | 1999-11-17 |
| K984108 | ABBOTT ARCHITECT B12 | Abbott Laboratories | 1999-02-03 |
| K903218 | IMX B12 | Abbott Laboratories | 1990-08-23 |
| K811927 | 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY | Corning Medical & Scientific | 1982-04-01 |
Legacy Summary#
summary
FDA Review#
Decision Summary