ORAL-EZE ORAL FLUID COLLECTION SYSTEM
FDA 510(k) clearance K984361 · decided 1999-01-13
Clearance details
- K-number
- K984361
- Device name
- ORAL-EZE ORAL FLUID COLLECTION SYSTEM
- Applicant
- Osborn Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-07
- Decision date
- 1999-01-13
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- PJD
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Olathe, KS, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Osborn Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Quantisal™ Oral Fluid Collection Device (K232898) | Immunalysis Corporation | 2023-11-21 |
| Quantisal™ II Oral Fluid Collection Device (K223781) | Immunalysis Corporation | 2023-07-28 |
| Quantisal Oral Fluid Collection Device (K200801) | Immunalysis Corporation | 2020-07-28 |
| Quantisal II Oral Fluid Collection Device (K183048) | Immunalysis Corporation | 2019-07-29 |
| INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX (K011057) | OraSure Technologies, Inc. | 2001-06-06 |
| EPISCREEN ORAL SPECIMEN COLLECTION DEVICE (K973395) | Epitope, Inc. | 1998-02-13 |
| EPISCREEN (K970357) | Epitope, Inc. | 1997-03-10 |
| SALIVA SAMPLER (K942435) | Saliva Diagnostic Systems, Inc. | 1995-08-21 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL recall (Z-1101-2012) | Capitol Vial Inc | 2012-02-24 |