FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENZYMUN-TEST TSH
K Number: K915195
·
Decision Feb 14, 1992
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
340
Review Days
87
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Basic Information
- Device Name
- ENZYMUN-TEST TSH
- K Number
- K915195
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- November 19, 1991
- Decision Date
- February 14, 1992
- 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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