Determin. of Salicylate in Serum/Plast
FDA 510(k) K840243 · Sigma Chemical Co.
510(k) numberK840243
Submission
- Device name
- Determin. of Salicylate in Serum/Plast
- Applicant
- Sigma Chemical Co.
Mchenry, IL, US - Received
- January 20, 1984
- Decision date
- March 23, 1984
- 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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| K951290 | Axsym SalicylateDKJ · Traditional | Abbott Laboratories | 08/08/1995SE |
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Questions and answers
When was Determin. of Salicylate in Serum/Plast cleared by the FDA?
Determin. of Salicylate in Serum/Plast (K840243) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 63 days after the submission was received.
What is the product code of K840243?
The FDA product code is DKJ – Colorimetry, Salicylate, a Class II (moderate risk) device regulated under 21 CFR 862.3830.