FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SIMUL-FER SERUM IRON TEST KIT
K Number: K820253
·
Decision May 12, 1982
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
66
Review Days
103
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Basic Information
- Device Name
- SIMUL-FER SERUM IRON TEST KIT
- K Number
- K820253
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1410
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Reagents, Inc.
- Date Received
- January 29, 1982
- Decision Date
- May 12, 1982
- 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.
DIAGNOSTIC KIT, FERRITAB-FE-59
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IRON 59 KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KIT, RADIOASSAY, SERUM IRON
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Diagnostic Reagents, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983268 | MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY | Nov 18, 1998 | Substantially Equivalent |
| K983812 | NAPA EIA ASSAY | Nov 16, 1998 | Substantially Equivalent |
| K983323 | DIGOXIN IMMUNOASSAY | Nov 12, 1998 | Substantially Equivalent |
| K983280 | VANCOMYCIN EIA ASSAY | Nov 6, 1998 | Substantially Equivalent |
| K983159 | DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS | Nov 5, 1998 | Substantially Equivalent |
| K973102 | LIDOCAINE EIA ASSAY | Sep 12, 1997 | Substantially Equivalent |
| K972835 | 50NG/ML COCAINE METABOLITE CALIBRATOR | Aug 28, 1997 | Substantially Equivalent |
| K972526 | METHADONE EIA ASSAY | Aug 4, 1997 | Substantially Equivalent |
| K964212 | QUINIDINE ENZYME IMMUNOASSAY | Dec 18, 1996 | Substantially Equivalent |
| K963835 | DIGOXIN ENZYME IMMUNOASSAY | Dec 10, 1996 | Substantially Equivalent |