PREFILLED IEC COLUMNS
FDA 510(k) clearance K831289 · decided 1983-06-16
Clearance details
- K-number
- K831289
- Device name
- PREFILLED IEC COLUMNS
- Applicant
- Berwick Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-20
- Decision date
- 1983-06-16
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- DJY
- Device class
- 1
- Regulation number
- 862.2230
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THE CDI(R) SYSTEM 400 (K890113) | Cardiovascular Devices, Inc. | 1989-05-23 |
| LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 (K883615) | Supelco, Inc. | 1988-12-16 |
| SOLID PHASE EXTRACTION TUBES (K881361) | Supelco, Inc. | 1988-08-08 |
| DUPONT PREP TYPE SI EXTRACITON CARTRIDGE (K850963) | E.I. Dupont DE Nemours & Co., Inc. | 1985-03-25 |
| TRISACRYL GF 05 & TRISACRYL GF 2000 (K840985) | Lkb Instruments, Inc. | 1984-04-19 |
| HC40/HC75 PREPACKED COLUMS (K832198) | Hamilton Co. | 1983-08-12 |
| DUPONT PREP TYPE AS EXTRACTION CARTRIDE (K830693) | E.I. Dupont DE Nemours & Co., Inc. | 1983-04-05 |
| DUPONT PREP OD EXTRACTION CARTRIDE (K830692) | E.I. Dupont DE Nemours & Co., Inc. | 1983-04-05 |
| PREP TYPE A EXTRACTION CARTRIDGE (K823697) | E.I. Dupont DE Nemours & Co., Inc. | 1983-01-05 |
| BOND ELUT COLUMNS (K800061) | Analytichem International, Inc. | 1980-03-12 |
Recalls involving this device
No recalls on record reference this clearance.