FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUORESCENCE CONCENTRATION ANALYZER (FCA)
K Number: K864699
·
Decision Dec 22, 1986
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
13
Applicant Total
2
Review Days
20
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Basic Information
- Device Name
- FLUORESCENCE CONCENTRATION ANALYZER (FCA)
- K Number
- K864699
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4520
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Pandex Laboratories, Inc.
- Date Received
- December 2, 1986
- Decision Date
- December 22, 1986
- Product Code
- JZT
- 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 |
|---|---|---|---|
| JZT | Fluorometer | FDA class 1 | Immunology |
Similar 510(k) Clearances
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Other Clearances by Pandex Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852240 | SMS, SCREEN MACHINE SYSTEM | Jun 11, 1985 | Substantially Equivalent |