510(k) K061841
- Device
- QUANTA LITE INTRINSIC FACTOR ELISA
- Applicant
- INOVA DIAGNOSTICS, INC.
- 510(k) number
- K061841
- Product code
- LIG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-12-22
- Date received
- 2006-06-29
- Regulation
- 862.1810
- Classification name
- Radioassay, Intrinsic Factor Blocking Antibody
- Medical specialty
- Clinical Chemistry
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARY L NORMAN
- Address
- 9900 Old Grove Rd. San Diego CA US 92131 92131
FDA Registration Numbers#
- 3002806944
- 2026994
- 3009518015
- 2432235
- 2122870
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K033603 | INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 | Beckman Coulter, Inc. | 2003-12-19 |
| 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#
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FDA Review#
Decision Summary