Unipak Hemoglobin
FDA 510(k) K771090 · Harleco
510(k) numberK771090
Submission
- Device name
- Unipak Hemoglobin
- Applicant
- Harleco
Mchenry, IL, US - Received
- June 16, 1977
- Decision date
- July 11, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKK – Cyanomethemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7500
- Specialty
- Hematology
Other 510(k)s with product code GKK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K896922 | Raichem TM Hemoglobin ReagentGKK · Traditional | Reagents Applications, Inc. | 01/25/1990SE |
| K894951 | Modified Hemoglobin Reagent SetGKK · Traditional | Macomb Biotechnology, Inc. | 10/24/1989SE |
| K883992 | KVM Prepack Hematology Reagent SetGKK · Traditional | Kvm Technologies, Inc. | 10/12/1988SE |
| K821202 | Hemoglobin Reagent SetGKK · Traditional | Omega Medical Electronics | 05/24/1982SE |
| K771716 | Cymet-PlusGKK · Traditional | J.T. Baker Chemical Co. | 09/20/1977SE |
| K770803 | Hemotology Produ&Ts (5 in All)GKK · Traditional | Hycel, Inc. | 07/05/1977SE |
More from Hycel, 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 Unipak Hemoglobin cleared by the FDA?
Unipak Hemoglobin (K771090) received a 510(k) decision of Substantially Equivalent on July 11, 1977, 25 days after the submission was received.
What is the product code of K771090?
The FDA product code is GKK – Cyanomethemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7500.