Hemotology Produ&Ts (5 in All)
FDA 510(k) K770803 · Hycel, Inc.
510(k) numberK770803
Submission
- Device name
- Hemotology Produ&Ts (5 in All)
- Applicant
- Hycel, Inc.
Mchenry, IL, US - Received
- May 2, 1977
- Decision date
- July 5, 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 |
| K771090 | Unipak HemoglobinGKK · Traditional | Harleco | 07/11/1977SE |
More from Harleco
| 510(k) | Device | Decision |
|---|---|---|
| K802422 | Hycel Trigyceride II Test · Traditional | 10/06/1980SESP |
| K790335 | Hycel MJJF · Traditional | 02/27/1979SE |
| K782176 | Hycel Ldh-Int TestCFH · Traditional | 01/26/1979SE |
| K782116 | Ketosteroid Test, HYCEL-17CCY · Traditional | 01/26/1979SE |
| K782102 | Hycel Counter 211GKL · Traditional | 01/03/1979SE |
| K782101 | Hycel Counter 222GKL · Traditional | 01/03/1979SE |
| K782100 | Hycel Counter 333GKL · Traditional | 01/03/1979SE |
| K781004 | Hma Uric Acid TestKNK · Traditional | 07/27/1978SE |
| K780946 | Royco Model 970 Hematology Data AnalyzerJPJ · Traditional | 07/27/1978SE |
| K780464 | Lelective Kinetic SYSTEM-60JJE · Traditional | 05/03/1978SE |
Questions and answers
When was Hemotology Produ&Ts (5 in All) cleared by the FDA?
Hemotology Produ&Ts (5 in All) (K770803) received a 510(k) decision of Substantially Equivalent on July 5, 1977, 64 days after the submission was received.
What is the product code of K770803?
The FDA product code is GKK – Cyanomethemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7500.