TOXOPLASMA GONDII
FDA 510(k) clearance K864981 · decided 1987-10-30
Clearance details
- K-number
- K864981
- Device name
- TOXOPLASMA GONDII
- Applicant
- Virion (U.S.), Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-22
- Decision date
- 1987-10-30
- Days to decision
- 312 days
- Clearance type
- Traditional
- Product code
- GMN
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Morristown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN (K894261) | Microbix Biosystems, Inc. | 1989-10-16 |
| AGGLUTINOTEST-TOXOPLASMOSIS (K791456) | Volu Sol Medical Industries | 1979-09-24 |
Recalls involving this device
No recalls on record reference this clearance.