Polymed Therapeutics, Inc.
Mission Viejo, CA, US
Polymed Therapeutics, Inc. appears in FDA device records in Mission Viejo, CA. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Polymed Therapeutics, Inc. between 2012 and 2014. The busiest year on record is 2013, with 2. The most recent is 2014, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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) | LDJ | Substantially Equivalent | |
| K132834 | FASTEP S10 HCG SERUM/URINE COMBO TEST | JHI | Substantially Equivalent | |
| K121065 | POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE | DKZ | Substantially Equivalent | |
| K122907 | FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER | LCX | Substantially Equivalent | |
| K112101 | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS | JHI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain