The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Cards Q.s. Hcg Or Concise Performance Plus Hcg.
| Device ID | K954273 |
| 510k Number | K954273 |
| Device Name: | CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | E. Joseph Mcmullen |
| Correspondent | E. Joseph Mcmullen QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-13 |
| Decision Date | 1995-10-16 |