SCEPTOR IDENTIFICATION SYSTEM
FDA 510(k) clearance K912897 · decided 1991-10-28
Clearance details
- K-number
- K912897
- Device name
- SCEPTOR IDENTIFICATION SYSTEM
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1991-07-01
- Decision date
- 1991-10-28
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- LQM
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Franklin Lakes, NJ, 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 |
|---|---|---|
| ROCHE OXI/FERM II (K923313) | Roche Diagnostic Systems, Inc. | 1993-04-05 |
| VITEK RAPID CALL-GRAM NEGATIV IDENT CARD (K925915) | Biomerieux Vitek, Inc. | 1993-03-23 |
| VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED (K911429) | Vitek Systems, Inc. | 1991-06-24 |
| SENSITITRE AUTO ID PLATE AP80 (K890057) | Radiometer America, Inc. | 1989-06-09 |
| GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (K862642) | American Micro Scan | 1986-09-11 |
| PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM (K851528) | Pasco Laboratories, Inc. | 1985-07-15 |
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 |