← Product Code [JBE](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBE) · K822733

# SIGMA REAGENT SYSTEM NO. 885 (K822733)

_Sigma Chemical Co. · JBE · Dec 3, 1982 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBE/K822733

## Device Facts

- **Applicant:** Sigma Chemical Co.
- **Product Code:** [JBE](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBE.md)
- **Decision Date:** Dec 3, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7100
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

Red blood cell enzyme assay is a device used to measure the activity in red blood cells of clinically important enzymatic reactions and their products, such as pyruvate kinase or 2,3-diphosphoglycerate. A red blood cell enzyme assay is used to determine the enzyme defects responsible for a patient's hereditary hemolytic anemia.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBE/K822733](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBE/K822733)

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