The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Quantisal Oral Fluid Collection Device.
| Device ID | K200801 |
| 510k Number | K200801 |
| Device Name: | Quantisal Oral Fluid Collection Device |
| Classification | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device |
| Applicant | Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767 |
| Contact | Wenying (jessica) Zhu |
| Correspondent | Wenying (jessica) Zhu Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767 |
| Product Code | PJD |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-27 |
| Decision Date | 2020-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937112168 | K200801 | 000 |
| 00840937112151 | K200801 | 000 |