FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
OraQuick Ebola Rapid Antigen Test
K Number: DEN190025
·
Decision Oct 10, 2019
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
0
Applicant Total
30
Review Days
150
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Basic Information
- Device Name
- OraQuick Ebola Rapid Antigen Test
- K Number
- DEN190025
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 866.4002
- Medical Specialty
- Microbiology
- Decision
- Unknown
- Applicant
- OraSure Technologies, Inc.
- Date Received
- May 13, 2019
- Decision Date
- October 10, 2019
- Product Code
- QID
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QID | Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens | FDA class 2 | Microbiology |
Other Clearances by OraSure Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K060859 | COMPOUND W FREEZE OFF WART REMOVAL SYSTEM | Jul 18, 2006 | Substantially Equivalent |
| K023487 | HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME | Mar 20, 2003 | Substantially Equivalent |
| K013882 | OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I | Apr 17, 2002 | Substantially Equivalent |
| K020371 | UPLINK TEST SYSTEM | Apr 3, 2002 | Substantially Equivalent |
| K011057 | INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX | Jun 6, 2001 | Substantially Equivalent |
| K002375 | STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I | Jan 26, 2001 | Substantially Equivalent |
| K001976 | STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I | Dec 6, 2000 | Substantially Equivalent |
| K002010 | STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 | Nov 29, 2000 | Substantially Equivalent |
| K000399 | STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 | May 15, 2000 | Substantially Equivalent |
| K001197 | COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA | May 11, 2000 | Substantially Equivalent |