FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROFLUOR READER
K Number: K822772
·
Decision Oct 27, 1982
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
27
Review Days
43
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Basic Information
- Device Name
- MICROFLUOR READER
- K Number
- K822772
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2560
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dynatech Corp.
- Date Received
- September 14, 1982
- Decision Date
- October 27, 1982
- Product Code
- KHO
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| KHO | Fluorometer, For Clinical Use | FDA class 1 | Clinical Chemistry |
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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 |
| K832117 | IMMULON SUBSTRATE REMOVAWELL STRIPS | Aug 8, 1983 | 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 |