Axsym Vancomycin II
FDA 510(k) K955851 · Abbott Laboratories
510(k) numberK955851
Submission
- Device name
- Axsym Vancomycin II
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- December 27, 1995
- Decision date
- May 9, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LEH – Radioimmunoassay, Vancomycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3950
- Specialty
- Clinical Toxicology
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| K032811 | Cedia Vancomycin AssayLEH · Traditional | Microgenics Corp. | 11/24/2003SE |
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Questions and answers
When was Axsym Vancomycin II cleared by the FDA?
Axsym Vancomycin II (K955851) received a 510(k) decision of Substantially Equivalent on May 9, 1996, 134 days after the submission was received.
What is the product code of K955851?
The FDA product code is LEH – Radioimmunoassay, Vancomycin, a Class II (moderate risk) device regulated under 21 CFR 862.3950.