CLOSTRIDIUM DIFFICILE
FDA 510(k) clearance K833136 · decided 1983-10-27
Clearance details
- K-number
- K833136
- Device name
- CLOSTRIDIUM DIFFICILE
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1983-09-14
- Decision date
- 1983-10-27
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- JSJ
- Device class
- 1
- Regulation number
- 866.2360
- 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 |
|---|---|---|
| POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (K882463) | Lakewood Biochemical Co., Inc. | 1988-06-22 |
| SABOURAUD MALTOSE AGAR (K881570) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| YM BROTH (K881571) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MYCOLOGICAL AGAR W/LOW PH (K881549) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| CHAPMAN STONE MEDIUM (K881526) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| PHYTONE YEAST EXTRACT AGAR (K881573) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| STREPTOSEL (K881578) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| BRILLIANT GREEN AGAR W/SULFADIAZINE (K881530) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| INHIBITORY MOLD AGAR (K881565) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MITIS SALIVARIUS AGAR (K881547) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TERGITOL 7 BROTH (K881561) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| LITTMAN AGAR (K881544) | Acumedia Manufacturers, Inc. | 1988-04-18 |
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 |