The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quickvue(tm) One-step Hcg Controls (posit/negati).
| Device ID | K931761 |
| 510k Number | K931761 |
| Device Name: | QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI) |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-08 |
| Decision Date | 1993-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613002727 | K931761 | 000 |