Liquispx Liquid Saliva or Unrine Drug of Abuse Control
FDA 510(k) K012907 · Clinical Controls
510(k) numberK012907
Submission
- Device name
- Liquispx Liquid Saliva or Unrine Drug of Abuse Control
- Applicant
- Clinical Controls
Hawaiian Gardens, CA, US - Received
- August 29, 2001
- Decision date
- September 28, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DIF – Drug Mixture Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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|---|---|---|---|
| K153474 | Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine…DIF · Traditional | Biochemical Diagnostics, Inc. | 02/23/2016SE |
| K132688 | Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, Au/NzDIF · Traditional | Biochemical Diagnostics, Inc. | 12/16/2013SE |
| K132174 | Multichem WBTDIF · Abbreviated | Techno-Path Manufacturing , Ltd. | 09/20/2013SE |
| K121122 | Detectabuse Liquid Control, Detectabuse Stat-Skreen Liquid ControlDIF · Traditional | Biochemical Diagnostic, Inc. | 07/03/2012SE |
| K121143 | Liquichek Whole Blood Immunosuppressant Control Tilevel (1,2 and 3)DIF · Traditional | Bio-Rad Laboratories | 05/18/2012SE |
| K120504 | Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine Toxicology…DIF · Traditional | Bio-Rad Laboratories, Inc. | 03/27/2012SE |
| K103656 | Thermo Scientific Mas R Doa TotalDIF · Traditional | Microgenics Corporation | 03/24/2011SE |
| K093577 | Liquichek Opiate ControlDIF · Traditional | Bio-Rad Laboratories | 03/12/2010SE |
| K080085 | Mas Tox ControlDIF · Traditional | Thermo Fisher Scientific | 04/30/2008SE |
| K080183 | Control Set Dat I, Contrl Set Dat II, Control Set Dat III, Control Set Amphetamine 1000…DIF · Abbreviated | Roche Diagnostics Corp. | 03/25/2008SE |
More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K964278 | Whole Blood Glucose Control Level 1,2,AND 3/WHOLE Blood Glucose Linearity…JJX · Traditional | 11/22/1996SE |
| K962432 | Liquispex Urine (Micro)Albumin ControlJJX · Traditional | 07/05/1996SE |
| K955691 | Serum Volatiles Control Level 1 & 2JJY · Traditional | 04/24/1996SE |
| K955690 | Aqueous Ethanol/Ammonia Control Level 1, 2, & 3JJY · Traditional | 04/24/1996SE |
| K946265 | Fibrinogen High Abnormal Control - Level 3GIL · Traditional | 08/24/1995SE |
| K935598 | Plasma Fibrinogen Control Level 1/LEVEL 2GIL · Traditional | 05/02/1995SE |
| K946266 | Ferritin Control - Level 1, 2, 3DGD · Traditional | 02/10/1995SE |
| K946050 | Liquispex(Tm) Liquid CRP Control Level 1 and 2DCK · Traditional | 02/10/1995SE |
| K946049 | Liquispex(Tm) Liquid B2M/CRP Control Level 1 and 2JJY · Traditional | 02/10/1995SE |
| K946048 | Liquispex(Tm) Liquid B2M Control Level 1 and 2JZG · Traditional | 02/10/1995SE |
Questions and answers
When was Liquispx Liquid Saliva or Unrine Drug of Abuse Control cleared by the FDA?
Liquispx Liquid Saliva or Unrine Drug of Abuse Control (K012907) received a 510(k) decision of Substantially Equivalent on September 28, 2001, 30 days after the submission was received.
What is the product code of K012907?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.