Dade Anemia/Hemochromatosis Contols,Level 1,LEVEL 2,AND Level 3
FDA 510(k) K933437 · Baxter Diagnostics, Inc.
510(k) numberK933437
Submission
- Device name
- Dade Anemia/Hemochromatosis Contols,Level 1,LEVEL 2,AND Level 3
- Applicant
- Baxter Diagnostics, Inc.
Miami, FL, US - Received
- July 14, 1993
- Decision date
- October 28, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Dade Anemia/Hemochromatosis Contols,Level 1,LEVEL 2,AND Level 3 cleared by the FDA?
Dade Anemia/Hemochromatosis Contols,Level 1,LEVEL 2,AND Level 3 (K933437) received a 510(k) decision of Substantially Equivalent on October 28, 1993, 106 days after the submission was received.
What is the product code of K933437?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.