Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart J — Products Used In Establishments That Manufacture Blood and Blood Products](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products) → [21 CFR 864.9600](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9600) → KSG — Media, Potentiating For In Vitro Diagnostic Use

# KSG · Media, Potentiating For In Vitro Diagnostic Use

_Hematology · 21 CFR 864.9600 · Class 2_

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

## Overview

- **Product Code:** KSG
- **Device Name:** Media, Potentiating For In Vitro Diagnostic Use
- **Regulation:** [21 CFR 864.9600](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9600)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K812565](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K812565.md) | ELUTION SOLUTION | Biological Corp. of America | Oct 23, 1981 | SESE |
| [K812222](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K812222.md) | EM-X | Biological Corp. of America | Sep 23, 1981 | SESE |
| [K800943](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K800943.md) | PENTEX BOVINE ALBUMIN 30% SOLUTION | Miles Laboratories, Inc. | May 8, 1980 | SESE |
| [K800189](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K800189.md) | BOVINE ALBUMIN 22% & 30% SOLUTIONS | Gotham Biologics, Inc. | Feb 13, 1980 | SESE |
| [K791791](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K791791.md) | ORTHO ANTIBODY ENHANCEMENT SOLUTION | Ortho Diagnostics, Inc. | Oct 11, 1979 | SESE |
| [K791113](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K791113.md) | LOW IONIC STRENGTH SOLUTION (LISS) | Hyland Therapeutic Div., Travenol Laboratories | Jun 28, 1979 | SESE |
| [K790973](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K790973.md) | LO-ION | Gamma Biologicals, Inc. | Jun 15, 1979 | SESE |
| [K790776](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K790776.md) | DADE LOW IONIC STRENGTH SOLUITION (LISS) | Dade, Baxter Travenol Diagnostics, Inc. | May 23, 1979 | SESE |
| [K790498](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K790498.md) | LISS REAGENT | Fisher Scientific Co., LLC | Apr 3, 1979 | SESE |
| [K781435](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K781435.md) | ORTHO LOW IONIC SOLUTION | Ortho Diagnostics, Inc. | Sep 14, 1978 | SESE |
| [K781397](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K781397.md) | EM-V | Biological Corp. of America | Sep 14, 1978 | SESE |
| [K780556](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K780556.md) | SPECT RIM (LISS) | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 24, 1978 | SESE |
| [K780413](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSG/K780413.md) | LOW IIONIC STRENGTH SOLUTION | Pfizer, Inc. | Apr 24, 1978 | SESE |

## Top Applicants

- Biological Corp. of America — 3 clearances
- Ortho Diagnostics, Inc. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Dade, Baxter Travenol Diagnostics, Inc. — 1 clearance
- Fisher Scientific Co., LLC — 1 clearance

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

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