SCEPTOR SYSTEM AUTOMATED MODEL 216
FDA 510(k) clearance K810229 · decided 1981-02-09
Clearance details
- K-number
- K810229
- Device name
- SCEPTOR SYSTEM AUTOMATED MODEL 216
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1981-01-27
- Decision date
- 1981-02-09
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- JTC
- Device class
- 1
- Regulation number
- 866.2500
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Walker, MI, 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 |
|---|---|---|
| FILTERMATE UNIVERSAL HARVESTER (K924907) | Packard Instrument Co., Inc. | 1992-12-01 |
| MICROMATE 196 MODEL A961960 (K901808) | Packard Instrument Co., Inc. | 1990-06-20 |
| IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (K894645) | Dynatech Laboratories, Inc. | 1989-10-17 |
| MULTI-PROBE HEAD PLUS (K892369) | Hamilton Co. | 1989-06-02 |
| GENETIC SYSTEMS MICROPLATE WASHER (K891768) | Genetic Systems Corp. | 1989-05-01 |
| GENETIC SYSTEMS MICROPLATE STRIP WASHER (K891766) | Genetic Systems Corp. | 1989-05-01 |
| GENETIC SYSTEMS PIPETTOR/DILUTOR (K891765) | Genetic Systems Corp. | 1989-05-01 |
| WASHER 500 MICROELISA SYSTEM (K884695) | Organon Teknika Corp. | 1988-12-13 |
| BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 (K884125) | Bio-Tek Instruments, Inc. | 1988-12-02 |
| DYNATECH MR 250 MANUAL MICROELISA READER (K874598) | Dynatech Laboratories, Inc. | 1987-11-20 |
| MICROPLATE AUTO-WASHER (MOTORIZED STAGE) (K873542) | Genetic Systems Corp. | 1987-09-23 |
| MICROLAB AT (K871945) | Hamilton Co. | 1987-05-29 |
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 |