The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quickvue(r) Chlamydia Test.
| Device ID | K946276 |
| 510k Number | K946276 |
| Device Name: | QUICKVUE(R) CHLAMYDIA TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| 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 | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-23 |
| Decision Date | 1995-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613200062 | K946276 | 000 |