LDZ — Fixative, Alcohol Containing Class I
FDA product code LDZ covers "Fixative, Alcohol Containing", a Class I medical device regulated under 21 CFR 864.4010. Submissions are reviewed by the Pathology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LDZ
- Device Class
- Class I
- Regulation Number
- 864.4010
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K883048 | alpha-tec systems | ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION | August 17, 1988 |
| K881922 | surgipath medical industries | CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE | May 25, 1988 |
| K881698 | alpha-tec systems | ATS PVA FIXATIVE SOLUTION | May 13, 1988 |
| K862725 | mill-rose laboratory | SACCOMANNO SPECIMAN SOLUTION | August 1, 1986 |
| K843428 | accra laboratories | BIOFIX | September 27, 1984 |
| K842913 | e k ind | WRIGHT STAIN FIXATIVE | September 7, 1984 |
| K831061 | american micro scan | PVA FIXATIVE/FORMALIN | June 8, 1983 |
| K761138 | zeus scientific | FA TISSUE FIXATIVE & WASH SET | January 6, 1978 |