QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
FDA 510(k) clearance K912442 · decided 1991-09-16
Clearance details
- K-number
- K912442
- Device name
- QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
- Applicant
- Quidel Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-03
- Decision date
- 1991-09-16
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- LYR
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| QUS-2 CALCANEAL ULTRASONOMETER (P990039/S001) | Quidel Corp. | 2003-06-19 |
| QUS-2 (TM) CALCANEAL ULTRASONOMETER (P990039) | Quidel Corp. | 2000-08-01 |