Abuscreen Online(R) Calibrators
FDA 510(k) K946000 · Roche Diagnostic Systems, Inc.
510(k) numberK946000
Submission
- Device name
- Abuscreen Online(R) Calibrators
- Applicant
- Roche Diagnostic Systems, Inc.
Somerville, NJ, US - Received
- December 6, 1994
- Decision date
- January 25, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DKJ – Colorimetry, Salicylate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3830
- Specialty
- Clinical Toxicology
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| K951290 | Axsym SalicylateDKJ · Traditional | Abbott Laboratories | 08/08/1995SE |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K983698 | Modification to Abuscreen Online BarbituratesDIS · Traditional | 05/03/1999SE |
| K983702 | Modification to Abuscreen Online for BenzoidiazepinesJXM · Traditional | 02/11/1999SE |
| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | 02/10/1999SE |
| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Abuscreen Online(R) Calibrators cleared by the FDA?
Abuscreen Online(R) Calibrators (K946000) received a 510(k) decision of Substantially Equivalent on January 25, 1995, 50 days after the submission was received.
What is the product code of K946000?
The FDA product code is DKJ – Colorimetry, Salicylate, a Class II (moderate risk) device regulated under 21 CFR 862.3830.