FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUADRA-TITER I.D.
K Number: K860208
·
Decision Mar 3, 1986
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
48
Applicant Total
12
Review Days
40
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Basic Information
- Device Name
- QUADRA-TITER I.D.
- K Number
- K860208
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Microtech Medical Systems, Inc.
- Date Received
- January 22, 1986
- Decision Date
- March 3, 1986
- Product Code
- JSS
- 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 |
|---|---|---|---|
| JSS | Kit, Identification, Enterobacteriaceae | FDA class 1 | Microbiology |
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Other Clearances by Microtech Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935485 | FAS FASTIDIOUS MIC PANEL | Feb 16, 1995 | Substantially Equivalent |
| K901598 | FASTIDIOUS MIC PANEL | Nov 8, 1990 | Substantially Equivalent |
| K896332 | SUPPLEMENT TO ANAEROBIC MIC PANEL | Feb 5, 1990 | Substantially Equivalent |
| K884831 | ANAEROBIC MIC PANEL | Mar 27, 1989 | Substantially Equivalent |
| K863847 | MIC - CONCEPT(TM) RX-2 | Dec 18, 1986 | Substantially Equivalent |
| K861774 | QUADRA-TITER (TM) I.D. (MODIFICATION) | May 20, 1986 | Substantially Equivalent |
| K852613 | MIC-CONCEPT SYSTEM | Sep 20, 1985 | Substantially Equivalent |
| K853745 | MIC-CONCEPT VIEWBOX | Sep 19, 1985 | Substantially Equivalent |
| K850725 | QUADRA TITER MICRO PLATES | Apr 30, 1985 | Substantially Equivalent |
| K851020 | MIC-CONCEPT INOCULATOR | Mar 29, 1985 | Substantially Equivalent |