SCEPTOR BETA-LACTAM PLUS MIC PANEL
FDA 510(k) clearance K844231 · decided 1984-11-07
Clearance details
- K-number
- K844231
- Device name
- SCEPTOR BETA-LACTAM PLUS MIC PANEL
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1984-10-30
- Decision date
- 1984-11-07
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- LTW
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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 |
|---|---|---|
| MIC-CONCEPT SYSTEM (K852613) | Microtech Medical Systems, Inc. | 1985-09-20 |
| PRECEPT CEFOPERAZONE (K853596) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT CEFTRIAXONE (K853273) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT TM CARBENICILLIN (K853685) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT METHICILLIN (K853772) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT TM MOXALACTAM (K853689) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT TM AMIKACIN (K853686) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT KANAMYCIN (K853684) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT NETILMICIN 32-13 (K853687) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT TM TOBRAMYCIN (K853688) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT ERYTHROMYCIN (K853053) | Austin Biological Laboratories | 1985-08-29 |
| PRECEPT AVGMENTIN (K853263) | Austin Biological Laboratories | 1985-08-29 |
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 |