SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ
FDA 510(k) clearance K132688 · decided 2013-12-16
Clearance details
- K-number
- K132688
- Device name
- SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ
- Applicant
- Biochemical Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-28
- Decision date
- 2013-12-16
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- DIF
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Edgewood, NY, 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 |
|---|
| Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series (K153474) | Biochemical Diagnostics, Inc. | 2016-02-23 |
| MULTICHEM WBT (K132174) | Techno-Path Manufacturing , Ltd. | 2013-09-20 |
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| LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) (K121143) | Bio-Rad Laboratories | 2012-05-18 |
| LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK (K120504) | Bio-Rad Laboratories, Inc. | 2012-03-27 |
| THERMO SCIENTIFIC MAS R DOA TOTAL (K103656) | Microgenics Corporation | 2011-03-24 |
| LIQUICHEK OPIATE CONTROL (K093577) | Bio-Rad Laboratories | 2010-03-12 |
| MAS TOX CONTROL (K080085) | Thermo Fisher Scientific | 2008-04-30 |
| CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 (K080183) | Roche Diagnostics Corp. | 2008-03-25 |
| LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC (K072721) | Bio-Rad, Diagnostics Grp. | 2007-12-11 |
| ESA LEADCARE II LEAD CONTROL (K063398) | Bionostics, Inc. | 2006-12-05 |
| DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 (K062191) | Dade Behring, Inc. | 2006-08-21 |
Recalls involving this device
No recalls on record reference this clearance.