← Product Code [KSG](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG) · K781435

# ORTHO LOW IONIC SOLUTION (K781435)

_Ortho Diagnostics, Inc. · KSG · Sep 14, 1978 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K781435

## Device Facts

- **Applicant:** Ortho Diagnostics, Inc.
- **Product Code:** [KSG](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG.md)
- **Decision Date:** Sep 14, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.9600
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K781435](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K781435)

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