The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quidel Ch50 Eq Eia.
| Device ID | K974111 |
| 510k Number | K974111 |
| Device Name: | QUIDEL CH50 EQ EIA |
| Classification | Complement C9, Antigen, Antiserum, Control |
| 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 | DAE |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-31 |
| Decision Date | 1998-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700012294 | K974111 | 000 |
| 30014613335566 | K974111 | 000 |