FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPINAL FLUID CONTROL
K Number: K851820
·
Decision Jul 15, 1985
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
16
Review Days
80
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Basic Information
- Device Name
- SPINAL FLUID CONTROL
- K Number
- K851820
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Irvine Scientific
- Date Received
- April 26, 1985
- Decision Date
- July 15, 1985
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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| K872102 | SPERM WASHING MEDIUM #9932 | Jul 16, 1987 | Substantially Equivalent |
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