Modified Hemoglobin Reagent Set
FDA 510(k) K894951 · Macomb Biotechnology, Inc.
510(k) numberK894951
Submission
- Device name
- Modified Hemoglobin Reagent Set
- Applicant
- Macomb Biotechnology, Inc.
Romeo, MI, US - Received
- July 20, 1989
- Decision date
- October 24, 1989
- 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 |
| 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 |
| K770803 | Hemotology Produ&Ts (5 in All)GKK · Traditional | Hycel, Inc. | 07/05/1977SE |
More from Hycel, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K871902 | The Uric Acid Reagent SetKNK · Traditional | 06/03/1987SE |
Questions and answers
When was Modified Hemoglobin Reagent Set cleared by the FDA?
Modified Hemoglobin Reagent Set (K894951) received a 510(k) decision of Substantially Equivalent on October 24, 1989, 96 days after the submission was received.
What is the product code of K894951?
The FDA product code is GKK – Cyanomethemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7500.