FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUIDEL HCG ENZYME IMMUNOASSAY KIT
K Number: K833156
·
Decision Nov 25, 1983
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
95
Applicant Total
93
Review Days
70
Basic Information
- Device Name
- QUIDEL HCG ENZYME IMMUNOASSAY KIT
- K Number
- K833156
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- QUIDEL CORP.
- Date Received
- September 16, 1983
- Decision Date
- November 25, 1983
- Product Code
- JHJ
- 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 |
|---|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
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