THE GOLDEN QUAD TEST (TOXO)
FDA 510(k) clearance K861122 · decided 1987-02-02
Clearance details
- K-number
- K861122
- Device name
- THE GOLDEN QUAD TEST (TOXO)
- Applicant
- Microbiological Research Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-03-25
- Decision date
- 1987-02-02
- Days to decision
- 314 days
- Clearance type
- Traditional
- Product code
- LJK
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Bountiful, UT, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL (K974261) | Boston Biomedica, Inc. | 1997-12-11 |
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| SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 (K861460) | Widran Urological Group, Ltd. | 1986-05-02 |
| TOXO IPA KIT IAN INDIRECT FLUORESCENT (K832069) | Bionetic Laboratory Products | 1983-09-26 |
| TOXOPLASMA GONDII ANTIBODY IGG (K822605) | Immulok, Inc. | 1982-10-27 |
Recalls involving this device
No recalls on record reference this clearance.