LDZ
8 FDA 510(k) clearances · Product code
32 daysmedian time to decision
406 days90th percentile
8clearances measured
FDA profile
- Official device name
- Fixative, Alcohol Containing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.4010
- Medical specialty
- Pathology
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION (K883048) | Alpha-Tec Systems, Inc. | 1988-08-17 |
| CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE (K881922) | Surgipath Medical Industries, Inc. | 1988-05-25 |
| ATS PVA FIXATIVE SOLUTION (K881698) | Alpha-Tec Systems, Inc. | 1988-05-13 |
| SACCOMANNO SPECIMAN SOLUTION (K862725) | Mill-Rose Laboratory | 1986-08-01 |
| BIOFIX (K843428) | Accra Laboratories, Inc. | 1984-09-27 |
| WRIGHT STAIN FIXATIVE (K842913) | E K Ind., Inc. | 1984-09-07 |
| PVA FIXATIVE/FORMALIN (K831061) | American Micro Scan | 1983-06-08 |
| FA TISSUE FIXATIVE & WASH SET (K761138) | Zeus Scientific, Inc. | 1978-01-06 |
Track LDZ automatically
Every clearance here is in the API, with alerts when new ones post.