SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101
FDA 510(k) clearance K861460 · decided 1986-05-02
Clearance details
- K-number
- K861460
- Device name
- SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101
- Applicant
- Widran Urological Group, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-18
- Decision date
- 1986-05-02
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- LJK
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Widran Urological Group
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL (K974261) | Boston Biomedica, Inc. | 1997-12-11 |
| 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 |
| 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.