# Polymed Therapeutics, Inc.

- Location (FDA's records): Mission Viejo, CA
- FDA decisions: 5 (2012–2014): 5 510(k) clearances
- Product codes: JHI (2), LCX (1), DKZ (1), LDJ (1)
- Predicates its devices cite: 11 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ACON Laboratories, Inc.: 7 (https://510kreport.com/company/acon-laboratories)
- Teco Diagnostics: 1 (https://510kreport.com/company/teco-diagnostics)
- International Newtech Development, Inc.: 1 (https://510kreport.com/company/international-newtech-development)
- Quidel Corp.: 1 (https://510kreport.com/company/quidel)
- First Check Diagnostics, LLC: 1 (https://510kreport.com/company/first-check-diagnostics)

## Firms that cite its devices most
- Assure Tech. (Hangzhou) Co, Ltd.: 1 (https://510kreport.com/company/assure-tech-hangzhou)
- Hangzhou AllTest Biotech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-alltest-biotech)

## Its most-cited devices
- K122907: Fastep at-Home Pregnancy, HCG, Over the Counter (2013), cited by 1
- K132834: Fastep S10 HCG Serum/Urine Combo Test (2014), cited by 1

## Recent decisions
- 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) (Sep 25, 2014)
- K132834: Fastep S10 HCG Serum/Urine Combo Test (Jan 9, 2014)
- K121065: Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device  and Dipcard Drugs of Abuse Screen Device (May 24, 2013)
- K122907: Fastep at-Home Pregnancy, HCG, Over the Counter (Mar 14, 2013)
- K112101: Fastep HCG Pregancy Serum/Urine Cassette and Dipstick Tests (Jul 17, 2012)

Source page: https://510kreport.com/company/polymed-therapeutics