# Medical Devices; Hematology and Pathology Devices; Classification of Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization
> **Food and Drug Administration** · Final order. · Published 2014-09-03 · Effective 2014-10-03 · 79 FR 52195
## Document
- **Document number:** 2014-20882
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 79 FR 52195
- **CFR reference:** 21 CFR 864
- **Publication date:** 2014-09-03
- **Effective date:** 2014-10-03
- **HHS docket:** Docket No. FDA-2014-N-1176
## Abstract

The Food and Drug Administration (FDA) is classifying early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the early growth response 1 (EGR1) gene fluorescence in-site hybridization (FISH) test system for specimen characterization classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2014/09/03/2014-20882/medical-devices-hematology-and-pathology-devices-classification-of-early-growth-response-1-gene)
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