SELECTICULT-CHLAMYDIA
FDA 510(k) clearance K852869 · decided 1985-09-19
Clearance details
- K-number
- K852869
- Device name
- SELECTICULT-CHLAMYDIA
- Applicant
- Scott Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-07-08
- Decision date
- 1985-09-19
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- LKH
- Device class
- 1
- Regulation number
- 866.3120
- 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.
| Record | Firm | Date |
|---|---|---|
| IPAZYME (TM) CHLAMYDIA IGG-IGA (K910644) | Savyon Diagnostics , Ltd. | 1991-03-19 |
| IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) (K901975) | Savyon Diagnostics , Ltd. | 1991-03-08 |
| IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT (K882674) | Icn Immunobiologicals | 1989-08-15 |
| CELLMATICS SHLAMYDIA DETECTION SYSTEM (K893669) | Difco Laboratories, Inc. | 1989-06-23 |
| CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT (K842151) | Bartels Immunodiagnostic Supplies, Inc. | 1984-07-20 |
| COMBION SKIN TEST (K830688) | Nicholas H. Maganias | 1983-03-31 |
| HISTOSET IMMUNOPEROXIDASE TISSURE KIT (K820390) | Immulok, Inc. | 1982-04-14 |
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 |