FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180
K Number: K932661
·
Decision Apr 17, 1996
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
1
Applicant Total
1
Review Days
1050
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Basic Information
- Device Name
- WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180
- K Number
- K932661
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Whatman Specialty Products, Inc.
- Date Received
- June 2, 1993
- Decision Date
- April 17, 1996
- Product Code
- PJC
- 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 |
|---|---|---|---|
| PJC | Newborn Screening Specimen Collection Paper | FDA class 2 | Clinical Chemistry |
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