HCG PREGNANCY ONE STEP TEST STRIP— 510(k) K934830
Substantially EquivalentTcpi, Inc.
FDA 510(k) clearance K934830 for HCG PREGNANCY ONE STEP TEST STRIP, Substantially Equivalent on 1993-12-02. 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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- K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
- 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.