510(k) K770803
- Device
- HEMOTOLOGY PRODU&TS (5 IN ALL)
- Applicant
- Hycel, Inc.
- 510(k) number
- K770803
- Product code
- GKK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-05
- Date received
- 1977-05-02
- Regulation
- 864.7500
- Classification name
- Cyanomethemoglobin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1219029
- 3023162659
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GKK#
| 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 |