FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT HTSH EIA DIAGNOSTIC KIT
K Number: K843540
·
Decision Nov 2, 1984
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
883
Review Days
56
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Basic Information
- Device Name
- ABBOTT HTSH EIA DIAGNOSTIC KIT
- K Number
- K843540
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- September 7, 1984
- Decision Date
- November 2, 1984
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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