Wiener Lab.Fer-Color Aa, Model 5X 20 ML Cat.N 1492003
FDA 510(k) K013097 · Wiener Laboratories Saic
510(k) numberK013097
Submission
- Device name
- Wiener Lab.Fer-Color Aa, Model 5X 20 ML Cat.N 1492003
- Applicant
- Wiener Laboratories Saic
Rosario, Santa Fe, AR - Received
- September 17, 2001
- Decision date
- November 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIY – Photometric Method, Iron (Non-Heme)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1410
- Specialty
- Clinical Chemistry
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| K972363 | Il Test IronJIY · Traditional | Instrumentation Laboratory CO | 08/15/1997SE |
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Questions and answers
When was Wiener Lab.Fer-Color Aa, Model 5X 20 ML Cat.N 1492003 cleared by the FDA?
Wiener Lab.Fer-Color Aa, Model 5X 20 ML Cat.N 1492003 (K013097) received a 510(k) decision of Substantially Equivalent on November 13, 2001, 57 days after the submission was received.
What is the product code of K013097?
The FDA product code is JIY – Photometric Method, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.