BARTELS TOXOPLASMA IGG EIA
FDA 510(k) clearance K922585 · decided 1992-09-02
Clearance details
- K-number
- K922585
- Device name
- BARTELS TOXOPLASMA IGG EIA
- Applicant
- Baxter Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-27
- Decision date
- 1992-09-02
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- LGD
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Bellevue, WA, US
- Third-party review
- No
- Expedited review
- No
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| LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II (K132234) | DiaSorin, Inc. | 2013-08-28 |
| LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II (K131441) | DiaSorin, Inc. | 2013-08-09 |
| VIDAS TOXO IGG AVIDITY (K101946) | bioMerieux, Inc. | 2011-05-18 |
| ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) (K102681) | Siemens Healthcare Diagnostics, Inc. | 2011-05-04 |
| PLATELIA TOXO IGM KIT MODEL 26211 (K090847) | Bio-Rad Laboratories | 2009-07-01 |
| ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG (K073501) | Roche Diagnostics Corp. | 2008-06-09 |
Recalls involving this device
No recalls on record reference this clearance.