FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
K Number: K991432
·
Decision Jun 2, 1999
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
85
Applicant Total
14
Review Days
37
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Basic Information
- Device Name
- BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
- K Number
- K991432
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biocheck, Inc.
- Date Received
- April 26, 1999
- Decision Date
- June 2, 1999
- Product Code
- KLI
- 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 |
|---|---|---|---|
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | FDA class 2 | Clinical Chemistry |
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| K992517 | BIOCHECK FERRITIN ELISA MODEL BC-1025 | Sep 24, 1999 | Substantially Equivalent |
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