K183048 is an FDA 510(k) clearance for the Quantisal II Oral Fluid Collection Device. This device is classified as a Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device (Class II - Special Controls, product code PJD).
Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on July 29, 2019, 269 days after receiving the submission on November 2, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675. Intended For Use In The Collection, Preservation, And Transport Of Oral Fluid Specimens For Drugs Of Abuse Or Alcohol Testing..
| 510(k) Number | K183048 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2018 |
| Decision Date | July 29, 2019 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | PJD — Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |
| Definition | Intended For Use In The Collection, Preservation, And Transport Of Oral Fluid Specimens For Drugs Of Abuse Or Alcohol Testing. |