FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DYNATECH MR4000 MICROPLATE READER
K Number: K904567
·
Decision Jan 28, 1991
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
27
Review Days
111
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Basic Information
- Device Name
- DYNATECH MR4000 MICROPLATE READER
- K Number
- K904567
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dynatech Corp.
- Date Received
- October 9, 1990
- Decision Date
- January 28, 1991
- Product Code
- JJQ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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| 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 |