The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Clinitest Hcg Pregnancy Test.
| Device ID | K032563 |
| 510k Number | K032563 |
| Device Name: | CLINITEST HCG PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | BAYER HEALTHCARE, LLC 63 NORTH ST. Medfield, MA 02052 |
| Contact | Mary Gray |
| Correspondent | Mary Gray BAYER HEALTHCARE, LLC 63 NORTH ST. Medfield, MA 02052 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-20 |
| Decision Date | 2003-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414473604 | K032563 | 000 |