The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for First Response Gold Digital Pregnancy Test.
Device ID | K070054 |
510k Number | K070054 |
Device Name: | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST |
Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
Applicant | CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543 |
Contact | Cynthia Davidson |
Correspondent | Cynthia Davidson CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543 |
Product Code | LCX |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-04 |
Decision Date | 2007-05-04 |
Summary: | summary |