510(k) K162208
- Device
- DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
- Applicant
- BECKMAN COULTER INC.
- 510(k) number
- K162208
- Product code
- CFN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-01-09
- Date received
- 2016-08-05
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Geraldine Fuentespina
- Address
- 250 S. Kraemer Blvd. Mail Stop E1.Se.01 Brea CA US 92821 92821
FDA Registration Numbers#
- 3006198300
- 3003795116
- 9610806
- 2050012
- 9680746
- 2432235
- 9610529
- 3012963943
- 2250051
- 1319808
- 3011989923
- 3004493545
- 3002642396
- 2050010
- 3012471076
- 9610126
- 1319681
- 3000308930
- 3000148879
- 9614373
Source Documents#
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 |
| 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 |
| K113823 | HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT | The Binding Site Group , Ltd. | 2013-03-27 |
Legacy Summary#
summary
FDA Review#
Decision Summary