PREDICTOR HOME PREGNANCY TEST— 510(k) K940637
Substantially EquivalentOrganon Teknika Corp.
FDA 510(k) clearance K940637 for PREDICTOR HOME PREGNANCY TEST, Substantially Equivalent on 1994-06-02. Applicant: Organon Teknika Corp.. Device class: 2.
Clearance details
- Applicant
- Organon Teknika 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
- Durham, NC, US
Recent devices under product code LCX
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- K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
- K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more
More clearances from Organon Teknika Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.