AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR
FDA 510(k) clearance K820396 · decided 1982-04-27
Clearance details
- K-number
- K820396
- Device name
- AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR
- Applicant
- Pheragen Technology Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-11
- Decision date
- 1982-04-27
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- GKT
- Device class
- 2
- Regulation number
- 864.9245
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |
|---|---|---|
| AMICUS Separator System (K200530) | Fresenius Kabi AG | 2020-09-11 |
| AMICUS Separator System, AMICUS Separator System; Refurbished (K162462) | Fresenius Kabi USA,Llc | 2016-11-23 |
| AUTOMATED BLOOD CELL SEPARATOR (K822521) | Cryosan, Inc. | 1982-09-30 |
| CELLTRIFUGE II (K801233) | Travenol Laboratories, S.A. | 1980-10-31 |
| STERILE, DISPOSABLE CENTRIFUGE BOWL (K791106) | Travenol Laboratories, S.A. | 1979-08-10 |
| TERUMO IMUGARD (K790105) | Terumo America, Inc. | 1979-05-24 |
| FILTER, EYRPUR DISPOSABLE LEUKOCITE (K781803) | Metrix Teknika, Inc. | 1979-01-17 |
| BLOOD CELL SEPARATOR 2997 (K771258) | Intl. Business Machines | 1977-09-06 |
| BLOOD CELL PROCESSOR MODEL 2 IBM 2991 (K760856) | Intl. Business Machines | 1977-01-10 |
Recalls involving this device
No recalls on record reference this clearance.