FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROBIOLOGICAL TRAY READER-MANUAL
K Number: K842947
·
Decision Sep 14, 1984
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
24
Review Days
50
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Basic Information
- Device Name
- MICROBIOLOGICAL TRAY READER-MANUAL
- K Number
- K842947
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- American Micro Scan
- Date Received
- July 26, 1984
- Decision Date
- September 14, 1984
- 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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Other Clearances by American Micro Scan
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|---|---|---|---|
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| K863776 | MICRODILUTION MIC PANELS | Feb 2, 1987 | Substantially Equivalent |
| K864674 | MICRODILUTION IDENTIFICATION PANELS | Jan 5, 1987 | Substantially Equivalent |
| K864389 | CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST | Dec 4, 1986 | Substantially Equivalent |
| K863038 | GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL | Sep 30, 1986 | Substantially Equivalent |
| K862642 | GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL | Sep 11, 1986 | Substantially Equivalent |
| K862332 | ANAEROBE RAPID CHROMOGENIC ID PANEL | Aug 27, 1986 | Substantially Equivalent |
| K862140 | MICRODILUTION PANELS | Jul 16, 1986 | Substantially Equivalent |
| K861584 | GRAM NEGATIVE COMBO PANEL TYPE 3 | Jun 17, 1986 | Substantially Equivalent |