BBL(R) DMACA INDOLE REAGENT DROPPERS
FDA 510(k) clearance K912480 · decided 1991-08-23
Clearance details
- K-number
- K912480
- Device name
- BBL(R) DMACA INDOLE REAGENT DROPPERS
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1991-06-03
- Decision date
- 1991-08-23
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- JTO
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Franklin Lake, NJ, US
- Third-party review
- No
- Expedited review
- No
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| IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (K050352) | Ameritek Research, LLC | 2005-09-01 |
| PYR SWAB (K970832) | Remel, Inc. | 1997-04-24 |
| GRAM SWAB (K970834) | Remel, Inc. | 1997-04-17 |
| INDOLE SWAB (K970833) | Remel, Inc. | 1997-04-02 |
| LYFO(TM) DIFFERENTIAL DISK-BACITRACIN (K970009) | Microbiologics, Inc. | 1997-02-06 |
| IDS RAPID CB PLUS SYSTEM (K962966) | Innovative Diagnostic Systems, Inc. | 1996-10-08 |
| COLISCREEN (K961191) | Hardy Diagnostics | 1996-06-17 |
| M. CAT BUTYRATE DISK (K960996) | Hardy Diagnostics | 1996-04-18 |
| GIBSON ID-M. CAT. (K955826) | Gibson Laboratories, Inc. | 1996-02-29 |
| DRYSLIDE CARTARRHALIS (K954783) | Difco Laboratories, Inc. | 1996-02-06 |
| LYFO(TM) DIFFERIENTAL DISK-PYR (K954812) | Microbiologics, Inc. | 1995-12-20 |
| GIBSON ID A.E. TEST (K953247) | Gibson Laboratories, Inc. | 1995-11-20 |
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 |