FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
PULSE IM RED CELL TEST
K Number: K923767
·
Decision Oct 16, 1992
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
58
Applicant Total
3
Review Days
80
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Basic Information
- Device Name
- PULSE IM RED CELL TEST
- K Number
- K923767
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pulse Scientific, Inc.
- Date Received
- July 28, 1992
- Decision Date
- October 16, 1992
- Product Code
- KTN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | FDA class 2 | Immunology |
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