SCOTT SELECTICULT-HSV ISOLATION &
FDA 510(k) clearance K841680 · decided 1984-10-30
Clearance details
- K-number
- K841680
- Device name
- SCOTT SELECTICULT-HSV ISOLATION &
- Applicant
- Scott Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-23
- Decision date
- 1984-10-30
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- GQL
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Fiskeville, RI, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S012) | Scott Laboratories, Inc. | 2016-03-15 |
| SEDASYS COMPUTER- ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S011) | Scott Laboratories, Inc. | 2016-02-12 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S010) | Scott Laboratories, Inc. | 2016-01-26 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S009) | Scott Laboratories, Inc. | 2015-10-08 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S007) | Scott Laboratories, Inc. | 2015-10-06 |
| SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S008) | Scott Laboratories, Inc. | 2015-07-16 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S005) | Scott Laboratories, Inc. | 2015-03-25 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEMS (P080009/S004) | Scott Laboratories, Inc. | 2015-03-23 |