FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAX-ACT
K Number: K983649
·
Decision Dec 11, 1998
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
23
Applicant Total
3
Review Days
56
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Basic Information
- Device Name
- MAX-ACT
- K Number
- K983649
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7140
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Array Medical, Inc.
- Date Received
- October 16, 1998
- Decision Date
- December 11, 1998
- Product Code
- JBP
- 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 |
|---|---|---|---|
| JBP | Activated Whole Blood Clotting Time | FDA class 2 | Hematology |
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