510(k) K833319
- Device
- BIO-REX 70 RESIN 100-200 MESH PH6.2
- Applicant
- BIOSAN LABORATORIES, INC.
- 510(k) number
- K833319
- Product code
- KEA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-11-03
- Date received
- 1983-09-26
- Regulation
- 862.2230
- Classification name
- Resins, Ion-exchange
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KEA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890997 | ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) | Atlantic Wholesale, Inc. | 1989-03-28 |
| K844948 | SYVA SOLID PHASE COLUMNS | Syva Co. | 1985-08-29 |
| K842028 | CM-TRISACRYL M DEAE-TRISACRYL M | Lkb Instruments, Inc. | 1984-06-07 |
| K833320 | AMBERLITE CG50 RESIN, 100-200 MESH | Biosan Laboratories, Inc. | 1983-12-08 |
| K831027 | EXTRELUT QE EXTRACTION COLUMNS | Emd Chemicals, Inc. | 1983-05-16 |
| K830918 | I.E.C COLUMN | Berwick Medical Products, Inc. | 1983-04-27 |
| K782066 | EXETRELUT | Mcb Manufacturing Chemists, Inc. | 1979-01-03 |
| K781728 | EXTUBE | Analytichem International, Inc. | 1978-12-20 |
Legacy Summary#
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FDA Review#
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