HZT
5 FDA 510(k) clearances · Product code
36 daysmedian time to decision
48 days90th percentile
5clearances measured
FDA profile
- Official device name
- Reagent, Schiff
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Medical specialty
- Hematology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1996: 1 · 1999: 1 · 2001: 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 |
|---|---|---|
| SCHIFF REAGENT (K883217) | Surgipath Medical Industries, Inc. | 1988-08-05 |
| SIGMA PERIODIC ACID-SCHIFF STAIN 395 (K843752) | Sigma Chemical Co. | 1984-10-30 |
| SCHIFF REAGENT FUCHSIN-SULFUROUS ACID (K842919) | E K Ind., Inc. | 1984-09-11 |
| SCHIFF REAGENT, PAS STAIN (K842917) | E K Ind., Inc. | 1984-09-07 |
| HISTOCHEMICAL PAS REACTION SET (K760031) | Harleco | 1976-07-20 |
Track HZT automatically
Every clearance here is in the API, with alerts when new ones post.