510(k) K232898
- Device
- Quantisal? Oral Fluid Collection Device
- Applicant
- Immunalysis Corporation
- 510(k) number
- K232898
- Product code
- PJD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-21
- Date received
- 2023-09-18
- Regulation
- 862.1675
- Classification name
- Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Shubhajit Mitra
- Address
- (An Abbott Rapid Diagnostics Company, Formerly Alere, Inc.) 829 Towne Center Dr. Pomona CA US 91767 91767
FDA Registration Numbers#
- 2020952
- 2029372
- 3010939897
- 3011945100
- 3008264082
Source Documents#
Other 510(k) Records For Product Code PJD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223781 | Quantisal™ II Oral Fluid Collection Device | Immunalysis Corporation | 2023-07-28 |
| K200801 | Quantisal Oral Fluid Collection Device | Immunalysis Corporation | 2020-07-28 |
| K183048 | Quantisal II Oral Fluid Collection Device | Immunalysis Corporation | 2019-07-29 |
| K011057 | INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX | OraSure Technologies, Inc. | 2001-06-06 |
| K984361 | ORAL-EZE ORAL FLUID COLLECTION SYSTEM | Osborn Laboratories, Inc. | 1999-01-13 |
| K973395 | EPISCREEN ORAL SPECIMEN COLLECTION DEVICE | Epitope, Inc. | 1998-02-13 |
| K970357 | EPISCREEN | Epitope, Inc. | 1997-03-10 |
| K942435 | SALIVA SAMPLER | Saliva Diagnostic Systems, Inc. | 1995-08-21 |