Histochemical Pas Reaction Set
FDA 510(k) K760031 · Harleco
510(k) numberK760031
Submission
- Device name
- Histochemical Pas Reaction Set
- Applicant
- Harleco
Mchenry, IL, US - Received
- June 14, 1976
- Decision date
- July 20, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HZT – Reagent, Schiff
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code HZT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883217 | Schiff ReagentHZT · Traditional | Surgipath Medical Industries, Inc. | 08/05/1988SE |
| K843752 | Sigma Periodic Acid-Schiff Stain 395HZT · Traditional | Sigma Chemical Co. | 10/30/1984SE |
| K842919 | Schiff Reagent Fuchsin-Sulfurous AcidHZT · Traditional | E K Ind., Inc. | 09/11/1984SE |
| K842917 | Schiff Reagent, Pas StainHZT · Traditional | E K Ind., Inc. | 09/07/1984SE |
More from E K Ind., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K820233 | Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional | 02/12/1982SE |
| K813427 | Ultrachem Gluc-DhLFR · Traditional | 12/31/1981SE |
| K813044 | Ultrachem Alb, Item #64970CIX · Traditional | 11/10/1981SE |
| K813043 | Ultrachem Crea Item #64972CGX · Traditional | 11/10/1981SE |
| K813042 | Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional | 11/10/1981SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | 11/10/1981SE |
| K813040 | Ultrachem Ca, Item #64975CJY · Traditional | 11/10/1981SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | 11/10/1981SE |
| K813038 | Ultrachem TP, Item #64974CEK · Traditional | 11/10/1981SE |
| K812594 | Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional | 10/02/1981SE |
Questions and answers
When was Histochemical Pas Reaction Set cleared by the FDA?
Histochemical Pas Reaction Set (K760031) received a 510(k) decision of Substantially Equivalent on July 20, 1976, 36 days after the submission was received.
What is the product code of K760031?
The FDA product code is HZT – Reagent, Schiff, a Class I (low risk) device regulated under 21 CFR 864.1850.