FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MSI-NAK-50 TEST KIT
K Number: K831300
·
Decision Jul 18, 1983
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
40
Review Days
88
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Basic Information
- Device Name
- MSI-NAK-50 TEST KIT
- K Number
- K831300
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1600
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Medical Specialties, Inc.
- Date Received
- April 21, 1983
- Decision Date
- July 18, 1983
- Product Code
- JGM
- 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 |
|---|---|---|---|
| JGM | Flame Photometry, Potassium | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JGM), ordered by most recent decision date.
LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SODIUM & POTASSIUM TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRIGLYCERIDE KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Medical Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K946201 | STAND, INFUSION | Apr 18, 1995 | Substantially Equivalent |
| K931947 | CHECKPOINT | Jun 18, 1993 | Substantially Equivalent |
| K926095 | REFRACTROL-SP | Jan 26, 1993 | Substantially Equivalent |
| K924926 | MSI-HCT | Jan 7, 1993 | Substantially Equivalent |
| K896566 | MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE | Feb 9, 1990 | Substantially Equivalent |
| K883703 | MSI-CAL 7 | Nov 22, 1988 | Substantially Equivalent |
| K883851 | MSI-CAL 8 | Nov 22, 1988 | Substantially Equivalent |
| K883850 | MSI-CAL 16 | Nov 22, 1988 | Substantially Equivalent |
| K880608 | MSI-PC | Mar 21, 1988 | Substantially Equivalent |
| K880270 | MSI-DIFF PLUS | Mar 1, 1988 | Substantially Equivalent |