510(k) K012296
- Device
- HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
- Applicant
- The Binding Site, Ltd.
- 510(k) number
- K012296
- Product code
- CFN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-31
- Date received
- 2001-07-20
- Regulation
- 866.5510
- Classification name
- Method, Nephelometric, Immunoglobulins (G, A, M)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- JAY H GELLER
- Address
- West Tower, Suite 4000 2425 W. Olympic Blvd. Santa Monica CA US 90404 90404
FDA Registration Numbers#
- 9614373
- 3006198300
- 3004493545
- 3011989923
- 9680746
- 1319808
- 3000308930
- 3012471076
- 3002642396
- 3000148879
- 9610126
- 3003795116
- 9610806
- 3012963943
- 2250051
- 2050012
- 9610529
- 2050010
- 2432235
- 1319681
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CFN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products GmbH | 2023-12-13 |
| K221114 | Immunoglobulin G (IgG) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023-08-02 |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlus | The Binding Site Group , Ltd. | 2019-09-04 |
| K191985 | Optilite IgA Kit | The Binding Site Group , Ltd. | 2019-08-19 |
| K191635 | Optilite IgM Kit | The Binding Site Group , Ltd. | 2019-07-15 |
| K191465 | Human IgM Kit for use on SPAPlus | The Binding Site Group , Ltd. | 2019-06-27 |
| K190686 | Optilite IgM CSF Kit | The Binding Site Group , Ltd. | 2019-05-28 |
| K183151 | Optilite IgA CSF Kit | The Binding Site Group , Ltd. | 2019-01-23 |
| K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent | Beckman Coulter, Inc. | 2017-01-09 |
| K150526 | Optilite IgG4 Kit | The Binding Site Group , Ltd. | 2015-05-30 |
| K142735 | The Optilite IgG3 kit | The Binding Site Group , Ltd. | 2014-12-21 |
| K130122 | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER | Beckman Coulter, Inc. | 2014-01-07 |
| K120901 | HUMAN IGA CSF KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | 2013-05-30 |
| K120750 | HUMAN IGM CSF KIT | The Binding Site Group , Ltd. | 2013-05-17 |
| K120749 | HUMAN IGG CSF KIT | The Binding Site Group , Ltd. | 2013-05-17 |