QUIX RAPID CHOLERA STRIP TEST
FDA 510(k) clearance K954995 · decided 1996-08-15
Clearance details
- K-number
- K954995
- Device name
- QUIX RAPID CHOLERA STRIP TEST
- Applicant
- Guardian Scientific, Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-10-31
- Decision date
- 1996-08-15
- Days to decision
- 289 days
- Clearance type
- Traditional
- Product code
- GSQ
- Device class
- 2
- Regulation number
- 866.3930
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Columbia, MD, 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 |
|---|---|---|
| CHOLERA SMART(TM) (K932622) | New Horizons Diagnostics Co. | 1995-06-27 |
| CHOLERASCREEN (K922432) | New Horizons Diagnostics Co. | 1992-12-07 |
Recalls involving this device
No recalls on record reference this clearance.