The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quickvue In-line One-step Strep A Control Swabs (positive & Negative Swab Specimens).
| Device ID | K945080 |
| 510k Number | K945080 |
| Device Name: | QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS) |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | Linda G Thoss |
| Correspondent | Linda G Thoss QUIDEL CORP. 10165 MCKELLAR COURT 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 | 1994-10-17 |
| Decision Date | 1995-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613003458 | K945080 | 000 |