K200801 is an FDA 510(k) clearance for the Quantisal 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 28, 2020, 123 days after receiving the submission on March 27, 2020.
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 | K200801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2020 |
| Decision Date | July 28, 2020 |
| Days to Decision | 123 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. |