GDS Enzymatic Salicylate Reagent
FDA 510(k) K882038 · Gds Technology, LLC
510(k) numberK882038
Submission
- Device name
- GDS Enzymatic Salicylate Reagent
- Applicant
- Gds Technology, LLC
Elkhart, IN, US - Received
- May 16, 1988
- Decision date
- June 24, 1988
- 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 |
|---|---|---|
| K020138 | Stat-Site MHGB Meter, Stat-Site MHGB Meter Card Holder, Stat-Site MHGB Test Cards…KHG · Special | 02/11/2002SE |
| K994073 | Hemosite Test SystemKHG · Traditional | 01/14/2000SE |
| K992132 | Cholesite Test SystemCHH · Traditional | 08/20/1999SE |
| K973649 | Hemosite Test SystemKHG · Traditional | 08/31/1998SE |
| K971145 | Glucosite Test SystemCGA · Traditional | 09/17/1997SE |
| K911801 | Ketosite(Tm)/Stat-Site(Tm)/Ketosite(Tm) Low-Hi ConJIN · Traditional | 07/01/1991SE |
| K880829 | GDS Enzymatic Acetaminophen ReagentLDP · Traditional | 05/27/1988SE |
Questions and answers
When was GDS Enzymatic Salicylate Reagent cleared by the FDA?
GDS Enzymatic Salicylate Reagent (K882038) received a 510(k) decision of Substantially Equivalent on June 24, 1988, 39 days after the submission was received.
What is the product code of K882038?
The FDA product code is DKJ – Colorimetry, Salicylate, a Class II (moderate risk) device regulated under 21 CFR 862.3830.