FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FILTERMATE UNIVERSAL HARVESTER
K Number: K924907
·
Decision Dec 1, 1992
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
65
Applicant Total
4
Review Days
63
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Basic Information
- Device Name
- FILTERMATE UNIVERSAL HARVESTER
- K Number
- K924907
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2500
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Packard Instrument Co., Inc.
- Date Received
- September 29, 1992
- Decision Date
- December 1, 1992
- Product Code
- JTC
- Advisory Committee
- Microbiology
- 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 |
|---|---|---|---|
| JTC | Device, Microtiter Diluting/Dispensing | FDA class 1 | Microbiology |
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