FDA product code HZT: Reagent, Schiff
HZT is the FDA product code for reagent, schiff. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 5 510(k) submissions under HZT, from 4 different applicants. The average 510(k) review took 34 days (median 36). FDA has posted 2 recalls for HZT devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Reagent, Schiff |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HZT clearance
Top HZT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 2 | 1984-09-11 |
| Surgipath Medical Industries, Inc. | 1 | 1988-08-05 |
| Sigma Chemical Co. | 1 | 1984-10-30 |
| Harleco | 1 | 1976-07-20 |
Most recent HZT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883217 | Surgipath Medical Industries, Inc. | SCHIFF REAGENT | 1988-08-05 | 7 |
| K843752 | Sigma Chemical Co. | SIGMA PERIODIC ACID-SCHIFF STAIN 395 | 1984-10-30 | 35 |
| K842919 | E K Ind., Inc. | SCHIFF REAGENT FUCHSIN-SULFUROUS ACID | 1984-09-11 | 48 |
| K842917 | E K Ind., Inc. | SCHIFF REAGENT, PAS STAIN | 1984-09-07 | 44 |
| K760031 | Harleco | HISTOCHEMICAL PAS REACTION SET | 1976-07-20 | 36 |
Recalls for HZT devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-01-26.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code HZT?
HZT is the FDA product code for reagent, schiff. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HZT?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HZT?
Across 5 cleared submissions the average was 34 days from receipt to decision (median 36).
Which companies have the most HZT clearances?
E K Ind., Inc. (2); Surgipath Medical Industries, Inc. (1); Sigma Chemical Co. (1); Harleco (1).
Have HZT devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2024-01-26.
Next steps
- Run an FDA pathway report with predicate devices for product code HZT
- Run a recall and safety report across every HZT manufacturer
- Watch product code HZT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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