AUTOZYME
FDA 510(k) clearance K760123 · decided 1976-07-20
Clearance details
- K-number
- K760123
- Device name
- AUTOZYME
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1976-06-28
- Decision date
- 1976-07-20
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- KSK
- Device class
- 2
- Regulation number
- 864.9400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Washington, DC, 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 |
|---|---|---|
| GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION (K813342) | Gamma Biologicals, Inc. | 1982-03-04 |
| FREEZE DRIED FICIN (K813404) | Biological Corp. of America | 1982-02-10 |
| FREEZE DRIED PAPAIN (K810803) | Biological Corp. of America | 1981-07-21 |
| AUTOMATED ENZYME (K780962) | Hyland Therapeutic Div., Travenol Laboratories | 1978-07-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |