FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
K Number: K854447
·
Decision Jan 3, 1986
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
24
Review Days
59
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Basic Information
- Device Name
- IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
- K Number
- K854447
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- American Micro Scan
- Date Received
- November 5, 1985
- Decision Date
- January 3, 1986
- Product Code
- GTZ
- Advisory Committee
- Microbiology
- 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 |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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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 |