Hi Chem Enzyme Linearity Standards (Prod. 88235)
FDA 510(k) K902321 · Hichem Diagnostics
510(k) numberK902321
Submission
- Device name
- Hi Chem Enzyme Linearity Standards (Prod. 88235)
- Applicant
- Hichem Diagnostics
Brea, CA, US - Received
- May 23, 1990
- Decision date
- June 28, 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 Hi Chem Enzyme Linearity Standards (Prod. 88235) cleared by the FDA?
Hi Chem Enzyme Linearity Standards (Prod. 88235) (K902321) received a 510(k) decision of Substantially Equivalent on June 28, 1990, 36 days after the submission was received.
What is the product code of K902321?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.