FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FERRITIRON KIT CAT. #RP-1100
K Number: K800710
·
Decision May 14, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
9
Review Days
44
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Basic Information
- Device Name
- FERRITIRON KIT CAT. #RP-1100
- K Number
- K800710
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1415
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ria Products, Inc.
- Date Received
- March 31, 1980
- Decision Date
- May 14, 1980
- Product Code
- JQG
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JQG | Radiometric, Fe59, Iron Binding Capacity | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JQG), ordered by most recent decision date.
COMBO-FER IRON DIAGNOSTIC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FERRO-QUANT TM FE 59 TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SPINSEP-FE59
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TOTAL IRON BINDING CAPACITY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Ria Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K813310 | NO-HOIL COMBOSTAT II KIT | Dec 17, 1981 | Substantially Equivalent |
| K802969 | CORTISOL 125-I RADIOIMMUNOASSAY KIT | Jan 2, 1981 | Substantially Equivalent |
| K801579 | VITAMIN B12 - NO-BOIL KIT | Oct 23, 1980 | Substantially Equivalent |
| K801578 | COMBOSTAT - NO-BOIL KIT | Oct 23, 1980 | Substantially Equivalent |
| K800914 | NO-BOIL FOLATE KIT #RP-500 | May 8, 1980 | Substantially Equivalent |
| K781844 | FERRITIN KIT | Jan 10, 1979 | Substantially Equivalent |
| K781769 | IRON 59 KIT | Dec 4, 1978 | Substantially Equivalent |
| K780148 | RIA FOR FOLATES & VIT. B12, COMBO KIT | Mar 3, 1978 | Substantially Equivalent |