FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS
K Number: K925859
·
Decision Jul 8, 1993
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
44
Applicant Total
5
Review Days
233
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Basic Information
- Device Name
- READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS
- K Number
- K925859
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Alamar Biosciences, Inc.
- Date Received
- November 17, 1992
- Decision Date
- July 8, 1993
- Product Code
- LRG
- 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 |
|---|---|---|---|
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | FDA class 2 | Microbiology |
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Other Clearances by Alamar Biosciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943756 | MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE | Feb 17, 1995 | Substantially Equivalent |
| K944723 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION | Oct 21, 1994 | Substantially Equivalent |
| K933885 | ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Nov 16, 1993 | Substantially Equivalent |
| K930478 | READAR | Oct 22, 1993 | Substantially Equivalent |