FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER
K Number: K962499
·
Decision Sep 5, 1996
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
13
Applicant Total
2
Review Days
71
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Basic Information
- Device Name
- ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER
- K Number
- K962499
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4520
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bartels, Inc.
- Date Received
- June 26, 1996
- Decision Date
- September 5, 1996
- 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 Bartels, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942820 | H292 | May 5, 1995 | Substantially Equivalent |