Du Pont Dimension(R) Salicylate(Sal) Method
FDA 510(k) K904301 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK904301
Submission
- Device name
- Du Pont Dimension(R) Salicylate(Sal) Method
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- September 19, 1990
- Decision date
- November 9, 1990
- 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
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| K961131 | Salicylate AssayDKJ · Traditional | Diagnostic Reagents, Inc. | 04/29/1996SE |
| K951290 | Axsym SalicylateDKJ · Traditional | Abbott Laboratories | 08/08/1995SE |
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Questions and answers
When was Du Pont Dimension(R) Salicylate(Sal) Method cleared by the FDA?
Du Pont Dimension(R) Salicylate(Sal) Method (K904301) received a 510(k) decision of Substantially Equivalent on November 9, 1990, 51 days after the submission was received.
What is the product code of K904301?
The FDA product code is DKJ – Colorimetry, Salicylate, a Class II (moderate risk) device regulated under 21 CFR 862.3830.