The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Rapidvue Hcg Test.
| Device ID | K102175 |
| 510k Number | K102175 |
| Device Name: | RAPIDVUE HCG TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | QUIDEL CORPORATION 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | Michelle Bodien |
| Correspondent | Michelle Bodien QUIDEL CORPORATION 10165 MCKELLAR COURT San Diego, CA 92121 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-02 |
| Decision Date | 2010-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613201120 | K102175 | 000 |