IDZ
5 FDA 510(k) clearances · Product code
16 daysmedian time to decision
30 days90th percentile
5clearances measured
FDA profile
- Official device name
- Cassettes, Tissue
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.3010
- Medical specialty
- Pathology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CASSETTE EMBOSSEER (K863483) | Surgipath Medical Industries, Inc. | 1986-09-16 |
| LYNX EL MICROSCOPY TISSUE PROCESSOR (K862457) | Australian Biomedical Corporation , Ltd. | 1986-07-16 |
| MACLEAN-FOGG, TISSUE CASSETTES (K833857) | Polymer Technology Corp. | 1983-12-02 |
| TISSUE CASSETTES FOR PROCESSING-EM BED (K831334) | Surgipath Medical Industries, Inc. | 1983-05-25 |
| LANCER PARAPLAST HISTO PROCESS CASSETTE (K760623) | Sherwood Medical Industries | 1976-09-27 |
Track IDZ automatically
Every clearance here is in the API, with alerts when new ones post.