The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quickvue Dipstick Strep A.
| Device ID | K011097 |
| 510k Number | K011097 |
| Device Name: | QUICKVUE DIPSTICK STREP A |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| 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 | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-11 |
| Decision Date | 2001-05-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613331452 | K011097 | 000 |
| 30014613201526 | K011097 | 000 |
| 30014613201250 | K011097 | 000 |
| 30014613201083 | K011097 | 000 |