IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
FDA 510(k) clearance K050741 · decided 2005-05-16
Clearance details
- K-number
- K050741
- Device name
- IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
- Applicant
- Ind Diagnostic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-21
- Decision date
- 2005-05-16
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- JHI
- 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
+ Add to Predicate Builder ◉ Watch Ind Diagnostic
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 recall (Z-0048-2024) | Universal Meditech Inc. | 2023-10-23 |
| DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 recall (Z-0064-2024) | Universal Meditech Inc. | 2023-10-23 |
| Accolade HFx These devices are modular components of a total hip system. These femoral ste recall (Z-0897-2009) | Stryker Howmedica Osteonics Corp. | 2009-01-26 |