FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROVIAL II #006-010-0201
K Number: K823773
·
Decision Jan 21, 1983
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
11
Applicant Total
27
Review Days
38
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Basic Information
- Device Name
- PROVIAL II #006-010-0201
- K Number
- K823773
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Dynatech Corp.
- Date Received
- December 14, 1982
- Decision Date
- January 21, 1983
- Product Code
- KDT
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KDT | Container, Specimen Mailer And Storage, Sterile | FDA class 1 | Pathology |
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|---|---|---|---|
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| K832117 | IMMULON SUBSTRATE REMOVAWELL STRIPS | Aug 8, 1983 | Substantially Equivalent |
| K823787 | HANDI-WASH | Mar 9, 1983 | Substantially Equivalent |
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| K830200 | MICROELISA MINIREADER II | Feb 16, 1983 | Substantially Equivalent |
| K823557 | REMOVAWELL PLATE LID | Dec 28, 1982 | Substantially Equivalent |
| K822962 | MICROFLUOR B REMOVAWELL STRIPS | Nov 16, 1982 | Substantially Equivalent |