FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW
K Number: K060968
·
Decision May 15, 2007
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
19
Applicant Total
1
Review Days
403
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Basic Information
- Device Name
- STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW
- K Number
- K060968
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wortham Laboratories, Inc.
- Date Received
- April 7, 2006
- Decision Date
- May 15, 2007
- Product Code
- GIZ
- 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 |
|---|---|---|---|
| GIZ | Plasma, Control, Normal | FDA class 2 | Hematology |
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