TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN
FDA 510(k) clearance K894261 · decided 1989-10-16
Clearance details
- K-number
- K894261
- Device name
- TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN
- Applicant
- Microbix Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-06-21
- Decision date
- 1989-10-16
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- GMN
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Flemington, 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 (K864981) | Virion (U.S.), Inc. | 1987-10-30 |
| AGGLUTINOTEST-TOXOPLASMOSIS (K791456) | Volu Sol Medical Industries | 1979-09-24 |
Recalls involving this device
No recalls on record reference this clearance.