BODYWISE PREGNANCEY TEST— 510(k) K941771
Substantially EquivalentCharlton Assoc.
FDA 510(k) clearance K941771 for BODYWISE PREGNANCEY TEST, Substantially Equivalent on 1994-07-06. Applicant: Charlton Assoc.. Device class: 2.
Clearance details
- Applicant
- Charlton Assoc.
- Product code
- Code LCX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code LCX
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- K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more
More clearances from Charlton Assoc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.