Liquichek Ck/Ld Isoenzyme Control; Levels 1 and 2
FDA 510(k) K903430 · Bio-Rad
510(k) numberK903430
Submission
- Device name
- Liquichek Ck/Ld Isoenzyme Control; Levels 1 and 2
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- July 31, 1990
- Decision date
- August 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Liquichek Ck/Ld Isoenzyme Control; Levels 1 and 2 cleared by the FDA?
Liquichek Ck/Ld Isoenzyme Control; Levels 1 and 2 (K903430) received a 510(k) decision of Substantially Equivalent on August 23, 1990, 23 days after the submission was received.
What is the product code of K903430?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.