Axsym Salicylate
FDA 510(k) K951290 · Abbott Laboratories
510(k) numberK951290
Submission
- Device name
- Axsym Salicylate
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- March 21, 1995
- Decision date
- August 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 |
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Questions and answers
When was Axsym Salicylate cleared by the FDA?
Axsym Salicylate (K951290) received a 510(k) decision of Substantially Equivalent on August 8, 1995, 140 days after the submission was received.
What is the product code of K951290?
The FDA product code is DKJ – Colorimetry, Salicylate, a Class II (moderate risk) device regulated under 21 CFR 862.3830.