The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Clinitek Hcg Test Strips.
Device ID | K971209 |
510k Number | K971209 |
Device Name: | CLINITEK HCG TEST STRIPS |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | BAYER CORP. 1884 MILES AVE. Elkhart, IN 46514 |
Contact | Roseanne Savol |
Correspondent | Nancy Sauer RDD CONSULTANTS, INC. 401 SPRUCE ST. Louisville, CO 80027 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 1997-04-02 |
Decision Date | 1997-04-04 |
Summary: | summary |