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 |