FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IRON BINDING CAPICITY MODEL 0370
K Number: K781865
·
Decision Dec 4, 1978
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
66
Applicant Total
47
Review Days
28
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Basic Information
- Device Name
- IRON BINDING CAPICITY MODEL 0370
- K Number
- K781865
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1410
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Stanbio Laboratory
- Date Received
- November 6, 1978
- Decision Date
- December 4, 1978
- Product Code
- JIY
- 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 |
|---|---|---|---|
| JIY | Photometric Method, Iron (Non-Heme) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIY), ordered by most recent decision date.
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
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DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
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SENTINEL IRON LIQUID
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VITALAB IRON REAGENT
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ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)
FDA 510(k)
FDA Class 1
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IRON-PC-SL ASSAY MODEL # 151-10, 151-26
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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