FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KM-KAL 6
K Number: K823022
·
Decision Nov 16, 1982
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
244
Applicant Total
12
Review Days
34
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Basic Information
- Device Name
- KM-KAL 6
- K Number
- K823022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Kmn Products, Inc.
- Date Received
- October 13, 1982
- Decision Date
- November 16, 1982
- Product Code
- JIT
- 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | FDA class 2 | Clinical Chemistry |
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Other Clearances by Kmn Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823044 | KM-KAL L3 | Dec 9, 1982 | Substantially Equivalent |
| K823019 | KM-KAL 3 | Nov 16, 1982 | Substantially Equivalent |
| K823021 | KM - KAL 5 | Nov 16, 1982 | Substantially Equivalent |
| K823020 | KM-KAL 4 | Nov 16, 1982 | Substantially Equivalent |
| K823024 | KM - KAL 1 | Nov 16, 1982 | Substantially Equivalent |
| K823025 | KM - KAL 2 | Nov 16, 1982 | Substantially Equivalent |
| K823023 | KM-KAL L6 | Nov 16, 1982 | Substantially Equivalent |
| K823043 | KM-KAL L2 | Nov 5, 1982 | Substantially Equivalent |
| K823045 | KM-KAL L4 | Nov 5, 1982 | Substantially Equivalent |
| K823042 | KM-KAL L1 | Nov 5, 1982 | Substantially Equivalent |