Dade(R) Ck-Mb/Myoglobin Immun Control, I,Ii,Iii
FDA 510(k) K926046 · Baxter Diagnostics, Inc.
510(k) numberK926046
Submission
- Device name
- Dade(R) Ck-Mb/Myoglobin Immun Control, I,Ii,Iii
- Applicant
- Baxter Diagnostics, Inc.
Miami, FL, US - Received
- December 1, 1992
- Decision date
- January 5, 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(R) Ck-Mb/Myoglobin Immun Control, I,Ii,Iii cleared by the FDA?
Dade(R) Ck-Mb/Myoglobin Immun Control, I,Ii,Iii (K926046) received a 510(k) decision of Substantially Equivalent on January 5, 1993, 35 days after the submission was received.
What is the product code of K926046?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.