NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG— 510(k) K850079
Substantially EquivalentBioclinical Systems, Inc.
FDA 510(k) clearance K850079 for NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG, Substantially Equivalent on 1985-03-05. Applicant: Bioclinical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Bioclinical Systems, 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
- St.Louis, MO, US
Recent devices under product code LCX
view all- K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
- K251053 — Shinetell PlusTM Digital Early Pregnancy Test
- 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 Bioclinical Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.