Cardio Rep LD Control - Cat No. 3325
FDA 510(k) K950801 · Helena Laboratories
510(k) numberK950801
Submission
- Device name
- Cardio Rep LD Control - Cat No. 3325
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- February 21, 1995
- Decision date
- March 30, 1995
- 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 LD Control - Cat No. 3325 cleared by the FDA?
Cardio Rep LD Control - Cat No. 3325 (K950801) received a 510(k) decision of Substantially Equivalent on March 30, 1995, 37 days after the submission was received.
What is the product code of K950801?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.