Advia Chemistry Salicylate Reagent
FDA 510(k) K093939 · Siemens Healthcare Diagnostics
510(k) numberK093939
Submission
- Device name
- Advia Chemistry Salicylate Reagent
- Applicant
- Siemens Healthcare Diagnostics
Tarrytown, NY, US - Received
- December 22, 2009
- Decision date
- May 19, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKJ – Colorimetry, Salicylate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3830
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DKJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042329 | Salicylate-Sl AssayDKJ · Traditional | Diagnostic Chemicals , Ltd. | 12/27/2004SE |
| K020794 | Salicylate Assay for the Advia Integrated Modular SystemDKJ · Traditional | Bayer Diagnostics Corp. | 07/11/2002SE |
| K014173 | Synchron Systems Salicylate Reagent and CalibratorDKJ · Traditional | Beckman Coulter, Inc. | 02/15/2002SE |
| K011878 | Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators…DKJ · Traditional | Syva Co. | 08/13/2001SE |
| K981872 | Salicylate-Sl Assay Catalogue Number 511-20,511-40DKJ · Traditional | Diagnostic Chemicals , Ltd. | 06/29/1998SE |
| K980032 | Salicylate Assay (Ace), Catalogue Number 501-71DKJ · Traditional | Diagnostic Chemicals , Ltd. | 03/02/1998SE |
| K964715 | Paramax Salicylate ReagentDKJ · Traditional | Dade Intl., Inc. | 04/25/1997SE |
| K961131 | Salicylate AssayDKJ · Traditional | Diagnostic Reagents, Inc. | 04/29/1996SE |
| K951290 | Axsym SalicylateDKJ · Traditional | Abbott Laboratories | 08/08/1995SE |
| K946000 | Abuscreen Online(R) CalibratorsDKJ · Traditional | Roche Diagnostic Systems, Inc. | 01/25/1995SE |
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Questions and answers
When was Advia Chemistry Salicylate Reagent cleared by the FDA?
Advia Chemistry Salicylate Reagent (K093939) received a 510(k) decision of Substantially Equivalent on May 19, 2010, 148 days after the submission was received.
What is the product code of K093939?
The FDA product code is DKJ – Colorimetry, Salicylate, a Class II (moderate risk) device regulated under 21 CFR 862.3830.