Product code GKK
- Device name
- Cyanomethemoglobin
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7500
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K896922 | RAICHEM TM HEMOGLOBIN REAGENT | Reagents Applications, Inc. | 1990-01-25 |
| K894951 | MODIFIED HEMOGLOBIN REAGENT SET | Macomb Biotechnology, Inc. | 1989-10-24 |
| K883992 | KVM PREPACK HEMATOLOGY REAGENT SET | Kvm Technologies, Inc. | 1988-10-12 |
| K821202 | HEMOGLOBIN REAGENT SET | Omega Medical Electronics | 1982-05-24 |
| K771716 | CYMET-PLUS | J.T. Baker Chemical Co. | 1977-09-20 |
| K771090 | UNIPAK HEMOGLOBIN | Harleco | 1977-07-11 |
| K770803 | HEMOTOLOGY PRODU&TS (5 IN ALL) | Hycel, Inc. | 1977-07-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00385480420143 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480492041 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480489553 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480489546 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485944 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485890 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485883 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485876 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485852 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485845 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485838 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485685 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485678 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485661 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485647 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485630 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485623 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485616 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485586 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480420181 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480420174 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480420136 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480492058 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |