BLOOD-SMEARING INSTRUMENT (MINIPREP TM)
FDA 510(k) clearance K760007 · decided 1976-09-03
Clearance details
- K-number
- K760007
- Device name
- BLOOD-SMEARING INSTRUMENT (MINIPREP TM)
- Applicant
- Geometric Data, Div. Smithkline Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-06-08
- Decision date
- 1976-09-03
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- GKJ
- Device class
- 1
- Regulation number
- 864.5850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| MICRO-MAT SYSTEM (K854962) | Ulster Scientific, Inc. | 1985-12-23 |
| MICRO-MAT SYSTEM (K854121) | Prevo Micro-Mat System | 1985-10-31 |
| E-Z PREP (K831558) | Coulter Electronics, Inc. | 1983-06-16 |
| HEMASPINNER (K811534) | Geometric Data, Div. Smithkline Corp. | 1981-08-18 |
| AUTOMATED SLIDE SPINNER (K771898) | Dynatech Cryomedical Co. | 1977-10-18 |
Recalls involving this device
No recalls on record reference this clearance.