Salicylate Stat-Pak
FDA 510(k) K813185 · Clin Tech Diagnostics Corp.
510(k) numberK813185
Submission
- Device name
- Salicylate Stat-Pak
- Applicant
- Clin Tech Diagnostics Corp.
Mchenry, IL, US - Received
- November 16, 1981
- Decision date
- November 24, 1981
- 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 |
|---|---|---|
| K821969 | Acetaminophen Stat-Pak Reagent SetLDP · Traditional | 07/16/1982SE |
| K820076 | Glyco-Sep Reagent Test SetLCP · Traditional | 02/12/1982SE |
| K810235 | Acetaminophen/Salicylate ControlDIF · Traditional | 02/10/1981SE |
| K802432 | Glyco-Trol Human Glycosylated Hom. Cont.LCP · Traditional | 12/01/1980SE |
Questions and answers
When was Salicylate Stat-Pak cleared by the FDA?
Salicylate Stat-Pak (K813185) received a 510(k) decision of Substantially Equivalent on November 24, 1981, 8 days after the submission was received.
What is the product code of K813185?
The FDA product code is DKJ – Colorimetry, Salicylate, a Class II (moderate risk) device regulated under 21 CFR 862.3830.