MODIFIED HEMOGLOBIN REAGENT SET
FDA 510(k) clearance K894951 · decided 1989-10-24
Clearance details
- K-number
- K894951
- Device name
- MODIFIED HEMOGLOBIN REAGENT SET
- Applicant
- Macomb Biotechnology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-20
- Decision date
- 1989-10-24
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- GKK
- Device class
- 2
- Regulation number
- 864.7500
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Romeo, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RAICHEM TM HEMOGLOBIN REAGENT (K896922) | Reagents Applications, Inc. | 1990-01-25 |
| KVM PREPACK HEMATOLOGY REAGENT SET (K883992) | Kvm Technologies, Inc. | 1988-10-12 |
| HEMOGLOBIN REAGENT SET (K821202) | Omega Medical Electronics | 1982-05-24 |
| CYMET-PLUS (K771716) | J.T. Baker Chemical Co. | 1977-09-20 |
| UNIPAK HEMOGLOBIN (K771090) | Harleco | 1977-07-11 |
| HEMOTOLOGY PRODU&TS (5 IN ALL) (K770803) | Hycel, Inc. | 1977-07-05 |
Recalls involving this device
No recalls on record reference this clearance.