GKK · Cyanomethemoglobin
Hematology · 21 CFR 864.7500 · Class 2
Overview
| Product Code | GKK |
|---|---|
| Device Name | Cyanomethemoglobin |
| Regulation | 21 CFR 864.7500 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.
Classification Rationale
Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K896922 | RAICHEM TM HEMOGLOBIN REAGENT | Reagents Applications, Inc. | Jan 25, 1990 | SESE |
| K894951 | MODIFIED HEMOGLOBIN REAGENT SET | Macomb Biotechnology, Inc. | Oct 24, 1989 | SESE |
| K883992 | KVM PREPACK HEMATOLOGY REAGENT SET | Kvm Technologies, Inc. | Oct 12, 1988 | SESE |
| K821202 | HEMOGLOBIN REAGENT SET | Omega Medical Electronics | May 24, 1982 | SESE |
| K771716 | CYMET-PLUS | J.T. Baker Chemical Co. | Sep 20, 1977 | SESE |
| K771090 | UNIPAK HEMOGLOBIN | Harleco | Jul 11, 1977 | SESE |
| K770803 | HEMOTOLOGY PRODU&TS (5 IN ALL) | Hycel, Inc. | Jul 5, 1977 | SESE |
Top Applicants
- Harleco — 1 clearance
- Hycel, Inc. — 1 clearance
- J.T. Baker Chemical Co. — 1 clearance
- Kvm Technologies, Inc. — 1 clearance
- Macomb Biotechnology, Inc. — 1 clearance
