ANASWAB
FDA 510(k) clearance K780159 · decided 1978-02-13
Clearance details
- K-number
- K780159
- Device name
- ANASWAB
- Applicant
- Scott Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-01-30
- Decision date
- 1978-02-13
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- JTX
- Device class
- 1
- Regulation number
- 866.2900
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ANAEROBIC ACCU-CULSHURE(TM) (K901645) | Medical Laboratory Automation Systems, Inc. | 1990-07-16 |
| ACUSON V328 AND C5432 TRANSDUCERS (K897151) | Acuson Corp. | 1990-07-03 |
| ACCU-CULSHURE TM (K882637) | Accu-Med Corp. | 1988-07-06 |
| BIO-BAG ENVIRONMENTAL CHAMBER (A & B) (K791724) | Marion Laboratories, Inc. | 1979-10-17 |
| STANDARDIZE TGCL & TGCH (K781376) | American Monitor Corp. | 1978-09-14 |
| PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE (K761241) | Gibco Laboratories Life Technologies, Inc. | 1976-12-30 |
| SPECIMEN COLLECTOR, ANAEROBIC (K760063) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-08-03 |
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 |