Salicylate Assay
FDA 510(k) K961131 · Diagnostic Reagents, Inc.
510(k) numberK961131
Submission
- Device name
- Salicylate Assay
- Applicant
- Diagnostic Reagents, Inc.
Sunnyvale, CA, US - Received
- March 21, 1996
- Decision date
- April 29, 1996
- 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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|---|---|---|---|
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| 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 |
| 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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| K983280 | Vancomycin Eia AssayLEH · Traditional | 11/06/1998SE |
| K983159 | Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional | 11/05/1998SE |
| K973102 | Lidocaine Eia AssayKLR · Traditional | 09/12/1997SE |
| K972835 | 50NG/ML Cocaine Metabolite CalibratorDLJ · Traditional | 08/28/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | 08/04/1997SE |
| K964212 | Quinidine Enzyme ImmunoassayLBZ · Traditional | 12/18/1996SE |
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Questions and answers
When was Salicylate Assay cleared by the FDA?
Salicylate Assay (K961131) received a 510(k) decision of Substantially Equivalent on April 29, 1996, 39 days after the submission was received.
What is the product code of K961131?
The FDA product code is DKJ – Colorimetry, Salicylate, a Class II (moderate risk) device regulated under 21 CFR 862.3830.