AGGLUTINOTEST-TOXOPLASMOSIS
FDA 510(k) clearance K791456 · decided 1979-09-24
Clearance details
- K-number
- K791456
- Device name
- AGGLUTINOTEST-TOXOPLASMOSIS
- Applicant
- Volu Sol Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1979-08-06
- Decision date
- 1979-09-24
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- GMN
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, 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 |
| TOXOPLASMA GONDII (K864981) | Virion (U.S.), Inc. | 1987-10-30 |
Recalls involving this device
No recalls on record reference this clearance.