HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE— 510(k) K941765
Substantially EquivalentTcpi, Inc.
FDA 510(k) clearance K941765 for HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE, Substantially Equivalent on 1994-10-20. Applicant: Tcpi, Inc.. Device class: 2.
Clearance details
- Applicant
- Tcpi, Inc.
- 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
- Ft. Lauderdale, FL, 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 Tcpi, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.