MSI-PC
FDA 510(k) clearance K880608 · decided 1988-03-21
Clearance details
- K-number
- K880608
- Device name
- MSI-PC
- Applicant
- Medical Specialties, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-02-12
- Decision date
- 1988-03-21
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- GJP
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- South Plainfield, NJ, 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 |
|---|---|---|
| HEMATOLOGY QUALITY CONTROL MIXTURE (K823930) | Fisher Scientific Co., LLC | 1983-02-01 |
| PLATELET CONTROLS NORMAL & ABNORMAL (K771588) | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-25 |
| 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.