FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Distinct® Early Detection Pregnancy Test
K Number: K193318
·
Decision Aug 20, 2020
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
225
Applicant Total
85
Review Days
262
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Basic Information
- Device Name
- Distinct® Early Detection Pregnancy Test
- K Number
- K193318
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACON Laboratories, Inc.
- Date Received
- December 2, 2019
- Decision Date
- August 20, 2020
- Product Code
- LCX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | FDA class 2 | Clinical Chemistry |
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