Hi Chem Total Protein/Albumin Serum Range Lin STND
FDA 510(k) K902673 · Hi Chem, Inc.
510(k) numberK902673
Submission
- Device name
- Hi Chem Total Protein/Albumin Serum Range Lin STND
- Applicant
- Hi Chem, Inc.
Brea, CA, US - Received
- June 18, 1990
- Decision date
- July 17, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- 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 Total Protein/Albumin Serum Range Lin STND cleared by the FDA?
Hi Chem Total Protein/Albumin Serum Range Lin STND (K902673) received a 510(k) decision of Substantially Equivalent on July 17, 1990, 29 days after the submission was received.
What is the product code of K902673?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.