RUBASCAN LATEX CARD TEST
FDA 510(k) clearance K832228 · decided 1983-09-29
Clearance details
- K-number
- K832228
- Device name
- RUBASCAN LATEX CARD TEST
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1983-07-11
- Decision date
- 1983-09-29
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- GOK
- Device class
- 2
- Regulation number
- 866.3510
- 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 |
|---|---|---|
| RUBAZYME - M (K810835) | Abbott Laboratories | 1981-05-05 |
| ANTIBODY TO RUBELLA VIRUS (K792635) | Electro-Nucleonics Laboratories, Inc. | 1980-03-19 |
| RUBELISA TEST KIT (K792133) | Microbiological Assoc. | 1980-01-11 |
| RUBANON (K790122) | Organon, Inc. | 1979-02-15 |
| RUBINDEX*DIRECT SYSTEM (K781638) | Ortho Diagnostics, Inc. | 1978-12-20 |
| CYTOMEGILISH TEST KIT (K781392) | Microbiological Assoc. | 1978-10-24 |
| GOAT ANTI-RUBELLA ANTISERA (K780010) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| RUBENOSTICON (K780063) | Organon, Inc. | 1978-01-20 |
| HUMAN O BUFFER (K771956) | Flow Laboratories, Inc. | 1977-10-28 |
| RUBELLA HEMAGGLUTINATION REAGENT KIT (K771957) | Flow Laboratories, Inc. | 1977-10-28 |
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 |