FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMULON SUBSTRATE REMOVAWELL STRIPS
K Number: K832117
·
Decision Aug 8, 1983
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
42
Applicant Total
27
Review Days
39
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Basic Information
- Device Name
- IMMULON SUBSTRATE REMOVAWELL STRIPS
- K Number
- K832117
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Dynatech Corp.
- Date Received
- June 30, 1983
- Decision Date
- August 8, 1983
- Product Code
- LIB
- Advisory Committee
- Microbiology
- 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 |
|---|---|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic | FDA class 1 | Microbiology |
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Other Clearances by Dynatech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K904567 | DYNATECH MR4000 MICROPLATE READER | Jan 28, 1991 | Substantially Equivalent |
| K854603 | MULTI MASH 2000 | Dec 6, 1985 | Substantially Equivalent |
| K854604 | AUTO MASH | Dec 6, 1985 | Substantially Equivalent |
| K854602 | MINI MASH 2000 | Dec 6, 1985 | Substantially Equivalent |
| K823787 | HANDI-WASH | Mar 9, 1983 | Substantially Equivalent |
| K823833 | MICRO STIX #011-010-5000 & HOLDER#5100 | Mar 8, 1983 | Substantially Equivalent |
| K830200 | MICROELISA MINIREADER II | Feb 16, 1983 | Substantially Equivalent |
| K823773 | PROVIAL II #006-010-0201 | Jan 21, 1983 | Substantially Equivalent |
| K823557 | REMOVAWELL PLATE LID | Dec 28, 1982 | Substantially Equivalent |
| K822962 | MICROFLUOR B REMOVAWELL STRIPS | Nov 16, 1982 | Substantially Equivalent |