FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
K Number: K993332
·
Decision Feb 16, 2000
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
39
Applicant Total
4
Review Days
135
Basic Information
- Device Name
- GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
- K Number
- K993332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GRADIPORE LTD.
- Date Received
- October 4, 1999
- Decision Date
- February 16, 2000
- Product Code
- GGC
- 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 |
|---|---|---|---|
| GGC | Control, Plasma, Abnormal | FDA class 2 | Hematology |
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