Submission Details
| 510(k) Number | K083716 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 15, 2008 |
| Decision Date | June 08, 2009 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
Jun 2009
Decision
175d
Days
Class 2
Risk
About This 510(k) Submission
K083716 is an FDA 510(k) clearance for the FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC), a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Church & Dwight Co., Inc. (Princeton, US). The FDA issued a Cleared decision on June 8, 2009, 175 days after receiving the submission on December 15, 2008. 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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