K232898 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 November 21, 2023, 64 days after receiving the submission on September 18, 2023.
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 | K232898 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2023 |
| Decision Date | November 21, 2023 |
| Days to Decision | 64 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. |