The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Cards Q.s. Hcg Serum/urine;concise Performance Plus Hcg-combo.
| Device ID | K973858 |
| 510k Number | K973858 |
| Device Name: | CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Contact | Robin Weiner |
| Correspondent | Robin Weiner QUIDEL CORP. 10165 MCKELLAR CT. 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 | 1997-10-09 |
| Decision Date | 1997-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613001799 | K973858 | 000 |
| 30014613001782 | K973858 | 000 |