The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Diagnostics Clinitest Pregnancy Test.
| Device ID | K023944 |
| 510k Number | K023944 |
| Device Name: | BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | BAYER CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Contact | Thomas F Flynn |
| Correspondent | Thomas F Flynn BAYER CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-26 |
| Decision Date | 2003-02-11 |
| Summary: | summary |