FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SANDARE IRON PROCEDURE
K Number: K851394
·
Decision Apr 30, 1985
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
66
Applicant Total
23
Review Days
21
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Basic Information
- Device Name
- SANDARE IRON PROCEDURE
- K Number
- K851394
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1410
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sandare Chemical Co., Inc.
- Date Received
- April 9, 1985
- Decision Date
- April 30, 1985
- 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)
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IRON-PC-SL ASSAY MODEL # 151-10, 151-26
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Sandare Chemical Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872852 | EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST | Sep 29, 1987 | Substantially Equivalent |
| K862556 | SANDARE GLYCOHEMOGLOBIN PROCEDURE | Aug 8, 1986 | Substantially Equivalent |
| K860684 | SANDARE BCG ALBUMIN PROCEDURE | Mar 17, 1986 | Substantially Equivalent |
| K851395 | SANDARE IRON-BINDING CAPACITY PROCEDURE | May 7, 1985 | Substantially Equivalent |
| K844498 | SANDARE ALKALINE PHOSPHATASE PROCEDURE | Dec 10, 1984 | Substantially Equivalent |
| K842516 | SANDARE ACID PHOSPHATASE PROCEDURE | Aug 17, 1984 | Substantially Equivalent |
| K833898 | TRI-LEVEL BILIRUBIN CONTROLS | Jan 13, 1984 | Substantially Equivalent |
| K832942 | TOTAL & DIRECT BILIRUBIN PROCEDURES | Nov 7, 1983 | Substantially Equivalent |
| K832632 | ALBUMIN PROCEDURE BCP | Sep 12, 1983 | Substantially Equivalent |
| K832183 | SANDARE CALCIUM PROCEDURE | Aug 24, 1983 | Substantially Equivalent |