ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
FDA 510(k) clearance K052694 · decided 2005-12-16
Clearance details
- K-number
- K052694
- Device name
- ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
- Applicant
- Ind Diagnostic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-28
- Decision date
- 2005-12-16
- Days to decision
- 79 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
No recalls on record reference this clearance.