PLATELET CONTROLS NORMAL & ABNORMAL
FDA 510(k) clearance K771588 · decided 1977-08-25
Clearance details
- K-number
- K771588
- Device name
- PLATELET CONTROLS NORMAL & ABNORMAL
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-08-18
- Decision date
- 1977-08-25
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- GJP
- Device class
- 2
- Regulation number
- 864.8625
- 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 |
|---|---|---|
| MSI-PC (K880608) | Medical Specialties, Inc. | 1988-03-21 |
| HEMATOLOGY QUALITY CONTROL MIXTURE (K823930) | Fisher Scientific Co., LLC | 1983-02-01 |
| LATELET DETERMIBATION KIT, UL 800 (K770655) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-06-24 |
Recalls involving this device
No recalls on record reference this clearance.