CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST— 510(k) K131931
Substantially EquivalentChemtron Biotech, Inc.
FDA 510(k) clearance K131931 for CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST, Substantially Equivalent on 2013-07-26. Applicant: Chemtron Biotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Chemtron Biotech, 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
- San Diego, CA, US
Recent devices under product code LCX
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- 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 Chemtron Biotech, Inc.
view all- K232736 — Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test
- K153192 — Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
- K143599 — Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000
- K142580 — Chemtrue Multi-Panel DOA DIP Card Tests
- K142396 — Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
Data sourced from openFDA. This site is unofficial and independent of the FDA.