Vancomycin Fpia Reagent Set
FDA 510(k) K955716 · Sigma Diagnostics, Inc.
510(k) numberK955716
Submission
- Device name
- Vancomycin Fpia Reagent Set
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- December 15, 1995
- Decision date
- February 16, 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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| K072036 | Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25…LEH · Traditional | Biokit, S.A. | 03/19/2008SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | Diagnostic Products Corp. | 12/05/2006SE |
| K060586 | Enzyme Immunoassay, VancomycinLEH · Traditional | Roche Diagnostics Corp. | 05/11/2006SE |
| K050419 | QMS VancomycinLEH · Traditional | Seradyn, Inc. | 04/01/2005SE |
| K043386 | Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers…LEH · Traditional | Ortho-Clinical Diagnostics, Inc. | 02/07/2005SE |
| K032811 | Cedia Vancomycin AssayLEH · Traditional | Microgenics Corp. | 11/24/2003SE |
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Questions and answers
When was Vancomycin Fpia Reagent Set cleared by the FDA?
Vancomycin Fpia Reagent Set (K955716) received a 510(k) decision of Substantially Equivalent on February 16, 1996, 63 days after the submission was received.
What is the product code of K955716?
The FDA product code is LEH – Radioimmunoassay, Vancomycin, a Class II (moderate risk) device regulated under 21 CFR 862.3950.