FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPINSEP-FE59
K Number: K790133
·
Decision Mar 2, 1979
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
22
Review Days
38
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Basic Information
- Device Name
- SPINSEP-FE59
- K Number
- K790133
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1415
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Nuclear Diagnostics, Inc.
- Date Received
- January 23, 1979
- Decision Date
- March 2, 1979
- 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)
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·Clinical Chemistry
FERRITIRON KIT CAT. #RP-1100
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FDA Class 1
·Clinical Chemistry
FERRO-QUANT TM FE 59 TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TOTAL IRON BINDING CAPACITY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Nuclear Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923917 | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY | Feb 25, 1994 | Substantially Equivalent |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | Dec 2, 1993 | Substantially Equivalent |
| K872177 | TIPSEP-CORTISOL RIA DIAGNOSTIC KIT | Jun 17, 1987 | Substantially Equivalent |
| K862312 | ENZLIPASE, ENZYMATIC LIPASE KIT | Sep 26, 1986 | Substantially Equivalent |
| K860472 | NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS | Jul 3, 1986 | Substantially Equivalent |
| K861735 | TIPSEP-TBG ASSAY | Jun 13, 1986 | Substantially Equivalent |
| K852291 | TIPSEP DIGOXIN RIA | Jun 25, 1985 | Substantially Equivalent |
| K833713 | SERUM THYROTROPIN ASSAY KIT, TIPSEP- | Dec 29, 1983 | Substantially Equivalent |
| K823860 | NUCLIPASE (I125) PANCREATIC LIPASE | Apr 18, 1983 | Substantially Equivalent |
| K811558 | TSH-P.E.G. | Jun 18, 1981 | Substantially Equivalent |