Submission Details
| 510(k) Number | K122907 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 21, 2012 |
| Decision Date | March 14, 2013 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
Mar 2013
Decision
174d
Days
Class 2
Risk
About This 510(k) Submission
K122907 is an FDA 510(k) clearance for the FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Polymed Therapeutics, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on March 14, 2013, 174 days after receiving the submission on September 21, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.
Device Classification
| Product Code | LCX — Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1155 |
Manufacturer
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