Salicylates
FDA 510(k) K813431 · Bio-Analytics Laboratories, Inc.
510(k) numberK813431
Submission
- Device name
- Salicylates
- Applicant
- Bio-Analytics Laboratories, Inc.
Mchenry, IL, US - Received
- December 8, 1981
- Decision date
- March 25, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K093939 | Advia Chemistry Salicylate ReagentDKJ · Traditional | Siemens Healthcare Diagnostics | 05/19/2010SE |
| 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 |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K861638 | Kinetic Alkaline Phosphatase Reagent KitCJE · Traditional | 05/29/1986SE |
| K860245 | Enzymatic Alpha-Amylase Reagent KitJFJ · Traditional | 03/14/1986SE |
| K860213 | Albumin Reagent KitCIX · Traditional | 02/11/1986SE |
| K851514 | Ultra-Violet Glucose ReagentCFA · Traditional | 05/20/1985SE |
| K851513 | Ultra-Violet Bun Reagent KitCDQ · Traditional | 05/20/1985SE |
| K850639 | Enzymatic Alpha-Amylase Reagent KitCIW · Traditional | 03/05/1985SE |
| K832771 | Erythrocyte TestLKZ · Traditional | 10/28/1983SE |
| K832567 | Acetaminophen(ParacetamolLDP · Traditional | 09/12/1983SE |
| K831414 | Colorimetric BunCDL · Traditional | 06/16/1983SE |
| K821934 | Bio-Cal Operation Check KitJIS · Traditional | 07/20/1982SE |
Questions and answers
When was Salicylates cleared by the FDA?
Salicylates (K813431) received a 510(k) decision of Substantially Equivalent on March 25, 1982, 107 days after the submission was received.
What is the product code of K813431?
The FDA product code is DKJ – Colorimetry, Salicylate, a Class II (moderate risk) device regulated under 21 CFR 862.3830.