Hichem Enzyme Verifier Kit
FDA 510(k) K943684 · Hi Chem, Inc.
510(k) numberK943684
Submission
- Device name
- Hichem Enzyme Verifier Kit
- Applicant
- Hi Chem, Inc.
Brea, CA, US - Received
- July 29, 1994
- Decision date
- October 4, 1994
- 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 Hichem Enzyme Verifier Kit cleared by the FDA?
Hichem Enzyme Verifier Kit (K943684) received a 510(k) decision of Substantially Equivalent on October 4, 1994, 67 days after the submission was received.
What is the product code of K943684?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.