Hdl-C/Ldl-C Calibrator, Model 1913-003
FDA 510(k) K993098 · Data Medical Associates, Inc.
510(k) numberK993098
Submission
- Device name
- Hdl-C/Ldl-C Calibrator, Model 1913-003
- Applicant
- Data Medical Associates, Inc.
Arlington, TX, US - Received
- September 16, 1999
- Decision date
- October 8, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K123321 | Dimension Chemistry III CalibratoryJIX · Traditional | Siemens Healthcare Diagnostics | 02/15/2013SE |
| K123372 | Abbott Lipid Multi Constituent CalibratorJIX · Traditional | Abbott Laboratories | 01/14/2013SE |
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Questions and answers
When was Hdl-C/Ldl-C Calibrator, Model 1913-003 cleared by the FDA?
Hdl-C/Ldl-C Calibrator, Model 1913-003 (K993098) received a 510(k) decision of Substantially Equivalent on October 8, 1999, 22 days after the submission was received.
What is the product code of K993098?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.