510(k) K894951
- Device
- MODIFIED HEMOGLOBIN REAGENT SET
- Applicant
- MACOMB BIOTECHNOLOGY, INC.
- 510(k) number
- K894951
- Product code
- GKK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-24
- Date received
- 1989-07-20
- Regulation
- 864.7500
- Classification name
- Cyanomethemoglobin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PEGGY MOUNTS
- Address
- 70001 Powell Rd., P.O. Box 466 Romeo MI US 48065 48065
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 |
| 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 |
Legacy Summary#
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FDA Review#
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