Media, Potentiating For In Vitro Diagnostic Use
This device is a potentiating medium for in vitro diagnostic use, such as low-ionic-strength solution (LISS) or albumin, used in blood bank serology to enhance the detection of clinically significant antibodies during antibody identification and compatibility testing. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KSG, regulated under 21 CFR 864.9600 within the Hematology specialty. No special flags apply.
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Basic Information
- Product Code
- KSG
- Device Class
- FDA class 2
- Regulation Number
- 864.9600
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K812565 | ELUTION SOLUTION | Oct 23, 1981 | Substantially Equivalent | Biological Corp. of America |
| K812222 | EM-X | Sep 23, 1981 | Substantially Equivalent | Biological Corp. of America |
| K800943 | PENTEX BOVINE ALBUMIN 30% SOLUTION | May 08, 1980 | Substantially Equivalent | Miles Laboratories, Inc. |
| K800189 | BOVINE ALBUMIN 22% & 30% SOLUTIONS | Feb 13, 1980 | Substantially Equivalent | Gotham Biologics, Inc. |
| K791791 | ORTHO ANTIBODY ENHANCEMENT SOLUTION | Oct 11, 1979 | Substantially Equivalent | Ortho Diagnostics, Inc. |
| K791113 | LOW IONIC STRENGTH SOLUTION (LISS) | Jun 28, 1979 | Substantially Equivalent | Hyland Therapeutic Div., Travenol Laboratories |
| K790973 | LO-ION | Jun 15, 1979 | Substantially Equivalent | Gamma Biologicals, Inc. |
| K790776 | DADE LOW IONIC STRENGTH SOLUITION (LISS) | May 23, 1979 | Substantially Equivalent | Dade, Baxter Travenol Diagnostics, Inc. |
| K790498 | LISS REAGENT | Apr 03, 1979 | Substantially Equivalent | Fisher Scientific Co., LLC |
| K781435 | ORTHO LOW IONIC SOLUTION | Sep 14, 1978 | Substantially Equivalent | Ortho Diagnostics, Inc. |
| K781397 | EM-V | Sep 14, 1978 | Substantially Equivalent | Biological Corp. of America |
| K780556 | SPECT RIM (LISS) | Apr 24, 1978 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K780413 | LOW IIONIC STRENGTH SOLUTION | Apr 24, 1978 | Substantially Equivalent | Pfizer, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.