PTK PLUS. HOME PREGNANCY TEST— 510(k) K861946
Substantially EquivalentHealthcheck Corp.
FDA 510(k) clearance K861946 for PTK PLUS. HOME PREGNANCY TEST, Substantially Equivalent on 1986-06-16. Applicant: Healthcheck Corp.. Device class: 2.
Clearance details
- Applicant
- Healthcheck Corp.
- 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
- Cheshire, CT, US
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More clearances from Healthcheck Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.