FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THROMBO-SCREEN AT-111 KIT
K Number: K770394
·
Decision Mar 30, 1977
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
55
Applicant Total
4
Review Days
30
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Basic Information
- Device Name
- THROMBO-SCREEN AT-111 KIT
- K Number
- K770394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7060
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Bay Area Hema. Onco. Clinic. & Res. L
- Date Received
- February 28, 1977
- Decision Date
- March 30, 1977
- Product Code
- JBQ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JBQ | Antithrombin Iii Quantitation | FDA class 2 | Hematology |
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