FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPLIANALYZER
K Number: K861958
·
Decision Aug 1, 1986
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
288
Applicant Total
3
Review Days
73
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Basic Information
- Device Name
- REPLIANALYZER
- K Number
- K861958
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1645
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Mct Medical, Inc.
- Date Received
- May 20, 1986
- Decision Date
- August 1, 1986
- Product Code
- LON
- 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 |
|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | FDA class 2 | Microbiology |
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