KSG · Media, Potentiating For In Vitro Diagnostic Use
Hematology · 21 CFR 864.9600 · Class 2
Overview
| Product Code | KSG |
|---|---|
| Device Name | Media, Potentiating For In Vitro Diagnostic Use |
| Regulation | 21 CFR 864.9600 |
| Device Class | Class 2 |
| Review Panel | Hematology |
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 | ELUTION SOLUTION | Biological Corp. of America | Oct 23, 1981 | SESE |
| K812222 | EM-X | Biological Corp. of America | Sep 23, 1981 | SESE |
| K800943 | PENTEX BOVINE ALBUMIN 30% SOLUTION | Miles Laboratories, Inc. | May 8, 1980 | SESE |
| K800189 | BOVINE ALBUMIN 22% & 30% SOLUTIONS | Gotham Biologics, Inc. | Feb 13, 1980 | SESE |
| K791791 | ORTHO ANTIBODY ENHANCEMENT SOLUTION | Ortho Diagnostics, Inc. | Oct 11, 1979 | SESE |
| K791113 | LOW IONIC STRENGTH SOLUTION (LISS) | Hyland Therapeutic Div., Travenol Laboratories | Jun 28, 1979 | SESE |
| K790973 | LO-ION | Gamma Biologicals, Inc. | Jun 15, 1979 | SESE |
| K790776 | DADE LOW IONIC STRENGTH SOLUITION (LISS) | Dade, Baxter Travenol Diagnostics, Inc. | May 23, 1979 | SESE |
| K790498 | LISS REAGENT | Fisher Scientific Co., LLC | Apr 3, 1979 | SESE |
| K781435 | ORTHO LOW IONIC SOLUTION | Ortho Diagnostics, Inc. | Sep 14, 1978 | SESE |
| K781397 | EM-V | Biological Corp. of America | Sep 14, 1978 | SESE |
| K780556 | SPECT RIM (LISS) | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 24, 1978 | SESE |
| K780413 | 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
