FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IRON 59 KIT
K Number: K781769
·
Decision Dec 4, 1978
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
9
Review Days
49
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Basic Information
- Device Name
- IRON 59 KIT
- K Number
- K781769
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1410
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ria Products, Inc.
- Date Received
- October 16, 1978
- Decision Date
- December 4, 1978
- Product Code
- JJA
- 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 |
|---|---|---|---|
| JJA | Radio-Labeled Iron Method, Iron (Non-Heme) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJA), ordered by most recent decision date.
SIMUL-FER SERUM IRON TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIAGNOSTIC KIT, FERRITAB-FE-59
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KIT, RADIOASSAY, SERUM IRON
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 |
| K800710 | FERRITIRON KIT CAT. #RP-1100 | May 14, 1980 | Substantially Equivalent |
| K800914 | NO-BOIL FOLATE KIT #RP-500 | May 8, 1980 | Substantially Equivalent |
| K781844 | FERRITIN KIT | Jan 10, 1979 | Substantially Equivalent |
| K780148 | RIA FOR FOLATES & VIT. B12, COMBO KIT | Mar 3, 1978 | Substantially Equivalent |