FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMBERLITE CG50 RESIN, 100-200 MESH
K Number: K833320
·
Decision Dec 8, 1983
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
8
Applicant Total
10
Review Days
73
Basic Information
- Device Name
- AMBERLITE CG50 RESIN, 100-200 MESH
- K Number
- K833320
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2230
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- BIOSAN LABORATORIES, INC.
- Date Received
- September 26, 1983
- Decision Date
- December 8, 1983
- Product Code
- KEA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KEA | Resins, Ion-Exchange | FDA class 1 | Clinical Chemistry |
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I.E.C COLUMN
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Other Clearances by BIOSAN LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K860642 | PHOTRON VISUAL FIELD ANALYZER | Apr 15, 1986 | Substantially Equivalent |
| K853812 | PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) | Nov 1, 1985 | Substantially Equivalent |
| K832763 | TOBRAMYCIN REAGENT | Mar 23, 1984 | Substantially Equivalent |
| K833193 | RADIOIMMUNOASSAY, THYROID STIMU. HORMONE | Feb 4, 1984 | Substantially Equivalent |
| K834023 | BIO-SCIENCE LABORATORIES T4 REAGENT | Jan 24, 1984 | Substantially Equivalent |
| K833318 | NORMAL GOAT SERUM | Jan 3, 1984 | Substantially Equivalent |
| K833192 | NORMAL URINE CONTROL | Dec 8, 1983 | Substantially Equivalent |
| K833191 | ABNORMAL URINE CONTROL | Dec 8, 1983 | Substantially Equivalent |
| K833319 | BIO-REX 70 RESIN 100-200 MESH PH6.2 | Nov 3, 1983 | Substantially Equivalent |