FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER— 510(k) K122907
Substantially EquivalentPolymed Therapeutics, Inc.
FDA 510(k) clearance K122907 for FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER, Substantially Equivalent on 2013-03-14. Applicant: Polymed Therapeutics, Inc.. Device class: 2.
Clearance details
- Applicant
- Polymed Therapeutics, 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
- Mission Viejo, CA, 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 Polymed Therapeutics, Inc.
view all- K142408 — FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
- K132834 — FASTEP S10 HCG SERUM/URINE COMBO TEST
- K121065 — POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
- K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.