IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
FDA 510(k) clearance K110889 · decided 2011-06-20
Clearance details
- K-number
- K110889
- Device name
- IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
- Applicant
- Ind Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-30
- Decision date
- 2011-06-20
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Delta, B.C., CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| One Step Pregnancy Test REF 100-01 recall (Z-0042-2024) | Universal Meditech Inc. | 2023-10-23 |
| PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF recall (Z-0053-2024) | Universal Meditech Inc. | 2023-10-23 |
| PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips recall (Z-0054-2024) | Universal Meditech Inc. | 2023-10-23 |