FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
P & T MEDIUM
K Number: K831059
·
Decision Apr 28, 1983
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
24
Review Days
27
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Basic Information
- Device Name
- P & T MEDIUM
- K Number
- K831059
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- American Micro Scan
- Date Received
- April 1, 1983
- Decision Date
- April 28, 1983
- Product Code
- JSM
- Advisory Committee
- Microbiology
- 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 |
|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | FDA class 1 | Microbiology |
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| 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 |