FDA 510(k)
Substantially Equivalent
🇺🇸 United States
NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC
K Number: K852976
·
Decision Dec 4, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
24
Review Days
142
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Basic Information
- Device Name
- NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC
- K Number
- K852976
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- American Micro Scan
- Date Received
- July 15, 1985
- Decision Date
- December 4, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- MI
- Third Party
- N
Other Clearances by American Micro Scan
| K Number | Device Name | ||
|---|---|---|---|
| K864662 | CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS | Mar 25, 1987 | Substantially Equivalent |
| K870029 | IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE | Mar 25, 1987 | Substantially Equivalent |
| 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 |