The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Positive Control Pad For Total Ige Test Dipstick.
| Device ID | K910082 |
| 510k Number | K910082 |
| Device Name: | POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | Craig E Watson |
| Correspondent | Craig E Watson QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-08 |
| Decision Date | 1991-03-12 |