Cardio Rep Recombinant CK Abnormal Control
FDA 510(k) K932442 · Helena Laboratories
510(k) numberK932442
Submission
- Device name
- Cardio Rep Recombinant CK Abnormal Control
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- May 20, 1993
- Decision date
- October 28, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJT – Enzyme Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Cardio Rep Recombinant CK Abnormal Control cleared by the FDA?
Cardio Rep Recombinant CK Abnormal Control (K932442) received a 510(k) decision of Substantially Equivalent on October 28, 1993, 161 days after the submission was received.
What is the product code of K932442?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.