The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quidel Total Ige Test Quantitative Version.
| Device ID | K894039 |
| 510k Number | K894039 |
| Device Name: | QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION |
| Classification | Ige, Peroxidase, Antigen, Antiserum, Control |
| Applicant | QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | Robin Weiner |
| Correspondent | Robin Weiner QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Product Code | DGO |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-06 |
| Decision Date | 1989-07-14 |