ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
FDA 510(k) clearance K974261 · decided 1997-12-11
Clearance details
- K-number
- K974261
- Device name
- ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
- Applicant
- Boston Biomedica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-13
- Decision date
- 1997-12-11
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- LJK
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- West Bridgewater, MA, 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 |
|---|---|---|
| ARD(TM) ANTIMICROBIAL REMOVAL DEVICE (K911771) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-07-01 |
| THE GOLDEN QUAD TEST (TOXO) (K861122) | Microbiological Research Corp. | 1987-02-02 |
| 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.