Histochemical Afb Demonstration
FDA 510(k) K771390 · Harleco
510(k) numberK771390
Submission
- Device name
- Histochemical Afb Demonstration
- Applicant
- Harleco
Mchenry, IL, US - Received
- July 27, 1977
- Decision date
- August 22, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ICL – Carbol Fuchsin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code ICL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K890148 | Ats TB Rapid Stain Set Product #034-45ICL · Traditional | Alpha-Tec Systems, Inc. | 01/24/1989SE |
| K842933 | Carbol-Fuchsin, Ziehl-NeedsenICL · Traditional | E K Ind., Inc. | 09/11/1984SE |
| K792483 | Stains, Counterstains & Gen. PurposeICL · Traditional | Laboratory Products, Inc. | 12/18/1979SE |
More from Laboratory Products, 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 Afb Demonstration cleared by the FDA?
Histochemical Afb Demonstration (K771390) received a 510(k) decision of Substantially Equivalent on August 22, 1977, 26 days after the submission was received.
What is the product code of K771390?
The FDA product code is ICL – Carbol Fuchsin, a Class I (low risk) device regulated under 21 CFR 864.1850.