← Product Code [GLY](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GLY) · K895466

# AVL MODEL 912 CO-OXYLITE (K895466)

_Avl Scientific Corp. · GLY · Nov 6, 1989 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GLY/K895466

## Device Facts

- **Applicant:** Avl Scientific Corp.
- **Product Code:** [GLY](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GLY.md)
- **Decision Date:** Nov 6, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7500
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.

## Special Controls

*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GLY/K895466](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GLY/K895466)

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