FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIME COLI KIT
K Number: K832587
·
Decision Oct 4, 1983
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
243
Applicant Total
45
Review Days
63
Basic Information
- Device Name
- RIME COLI KIT
- K Number
- K832587
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- AUSTIN BIOLOGICAL LABORATORIES
- Date Received
- August 2, 1983
- Decision Date
- October 4, 1983
- Product Code
- JTO
- 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | FDA class 1 | Microbiology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K862560 | PRECEPT CEFTIZOXIME | Jul 11, 1986 | Substantially Equivalent |
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| K860195 | PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE | Feb 20, 1986 | Substantially Equivalent |
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| K853596 | PRECEPT CEFOPERAZONE | Sep 16, 1985 | Substantially Equivalent |