The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quidel Molecular Direct C. Difficile Assay.
| Device ID | K123998 |
| 510k Number | K123998 |
| Device Name: | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY |
| Classification | C. Difficile Toxin Gene Amplification Assay |
| Applicant | QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Contact | Ronald H Lollar |
| Correspondent | Ronald H Lollar QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Product Code | OZN |
| CFR Regulation Number | 866.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613311058 | K123998 | 000 |