FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WRIGHTS RAPID STAIN
K Number: K801212
·
Decision May 30, 1980
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
32
Applicant Total
5
Review Days
10
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Basic Information
- Device Name
- WRIGHTS RAPID STAIN
- K Number
- K801212
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Mcb Manufacturing Chemists, Inc.
- Date Received
- May 20, 1980
- Decision Date
- May 30, 1980
- Product Code
- IAF
- 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 |
|---|---|---|---|
| IAF | Wright'S Stain | FDA class 1 | Hematology |
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