FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAF FIXATIVE
K Number: K831058
·
Decision Jun 8, 1983
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
3
Applicant Total
24
Review Days
68
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Basic Information
- Device Name
- SAF FIXATIVE
- K Number
- K831058
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- American Micro Scan
- Date Received
- April 1, 1983
- Decision Date
- June 8, 1983
- Product Code
- LDW
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| LDW | Fixative, Acid Containing | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDW), ordered by most recent decision date.
ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID
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PICRIC ACID 1% W/V
FDA 510(k)
FDA Class 1
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PICRIC ACID SATURATED SOLUTION
FDA 510(k)
FDA Class 1
·Pathology
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 |