510(k) K831289
- Device
- PREFILLED IEC COLUMNS
- Applicant
- BERWICK MEDICAL PRODUCTS, INC.
- 510(k) number
- K831289
- Product code
- DJY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-06-16
- Date received
- 1983-04-20
- Regulation
- 862.2230
- Classification name
- Ion-exchange Chromatography
- 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
FDA Registration Numbers#
- 3034725654
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DJY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890113 | THE CDI(R) SYSTEM 400 | Cardiovascular Devices, Inc. | 1989-05-23 |
| K883615 | LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 | Supelco, Inc. | 1988-12-16 |
| K881361 | SOLID PHASE EXTRACTION TUBES | Supelco, Inc. | 1988-08-08 |
| K850963 | DUPONT PREP TYPE SI EXTRACITON CARTRIDGE | E.I. Dupont DE Nemours & Co., Inc. | 1985-03-25 |
| K840985 | TRISACRYL GF 05 & TRISACRYL GF 2000 | Lkb Instruments, Inc. | 1984-04-19 |
| K832198 | HC40/HC75 PREPACKED COLUMS | Hamilton Co. | 1983-08-12 |
| K830692 | DUPONT PREP OD EXTRACTION CARTRIDE | E.I. Dupont DE Nemours & Co., Inc. | 1983-04-05 |
| K830693 | DUPONT PREP TYPE AS EXTRACTION CARTRIDE | E.I. Dupont DE Nemours & Co., Inc. | 1983-04-05 |
| K823697 | PREP TYPE A EXTRACTION CARTRIDGE | E.I. Dupont DE Nemours & Co., Inc. | 1983-01-05 |
| K800061 | BOND ELUT COLUMNS | Analytichem International, Inc. | 1980-03-12 |
Legacy Summary#
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FDA Review#
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