FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROLYTE
K Number: K820541
·
Decision May 24, 1982
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
12
Review Days
83
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Basic Information
- Device Name
- MICROLYTE
- K Number
- K820541
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Kone Instruments, Inc.
- Date Received
- March 2, 1982
- Decision Date
- May 24, 1982
- Product Code
- JJF
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Kone Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873345 | 'MICROLYTE 4/5' | Sep 11, 1987 | Substantially Equivalent |
| K870777 | PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER | Mar 13, 1987 | Substantially Equivalent |
| K863466 | M700 STRESS MONITOR | Dec 22, 1986 | Substantially Equivalent |
| K862655 | SIGNA II RESTING ECG ELECTRODE | Aug 6, 1986 | Substantially Equivalent |
| K860767 | MODEL E 600 ELECTROCARDIOGRAPH | Apr 23, 1986 | Substantially Equivalent |
| K853354 | MEDIC 4 | Oct 11, 1985 | Substantially Equivalent |
| K840200 | PROGRESS SELECTIVE DHEMISTRY ANALYZ | Apr 4, 1984 | Substantially Equivalent |
| K830433 | PATIENT MONITOR 575 | Mar 24, 1983 | Substantially Equivalent |
| K830432 | CENTRAL STATION 590 | Mar 24, 1983 | Substantially Equivalent |
| K822952 | 560 | Nov 1, 1982 | Substantially Equivalent |