KSG — Media, Potentiating For In Vitro Diagnostic Use Class II
FDA product code KSG covers "Media, Potentiating For In Vitro Diagnostic Use", a Class II medical device regulated under 21 CFR 864.9600. Submissions are reviewed by the Hematology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KSG
- Device Class
- Class II
- Regulation Number
- 864.9600
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K812565 | biological corp. of america | ELUTION SOLUTION | October 23, 1981 |
| K812222 | biological corp. of america | EM-X | September 23, 1981 |
| K800943 | miles laboratories | PENTEX BOVINE ALBUMIN 30% SOLUTION | May 8, 1980 |
| K800189 | gotham biologics | BOVINE ALBUMIN 22% & 30% SOLUTIONS | February 13, 1980 |
| K791791 | ortho diagnostics | ORTHO ANTIBODY ENHANCEMENT SOLUTION | October 11, 1979 |
| K791113 | hyland therapeutic div., travenol laboratories | LOW IONIC STRENGTH SOLUTION (LISS) | June 28, 1979 |
| K790973 | gamma biologicals | LO-ION | June 15, 1979 |
| K790776 | dade, baxter travenol diagnostics | DADE LOW IONIC STRENGTH SOLUITION (LISS) | May 23, 1979 |
| K790498 | fisher scientific co | LISS REAGENT | April 3, 1979 |
| K781397 | biological corp. of america | EM-V | September 14, 1978 |
| K781435 | ortho diagnostics | ORTHO LOW IONIC SOLUTION | September 14, 1978 |
| K780556 | bd becton dickinson vacutainer systems preanalytic | SPECT RIM (LISS) | April 24, 1978 |
| K780413 | pfizer | LOW IIONIC STRENGTH SOLUTION | April 24, 1978 |