510(k) K880608
- Device
- MSI-PC
- Applicant
- MEDICAL SPECIALTIES, INC.
- 510(k) number
- K880608
- Product code
- GJP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-03-21
- Date received
- 1988-02-12
- Regulation
- 864.8625
- Classification name
- Control, Platelet
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RON DEVITA
- Address
- 3610 Kennedy Rd. South Plainfield NJ US 07080 07080
FDA Registration Numbers#
- 9613959
- 3014150341
- 3009711478
- 1950302
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GJP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K823930 | HEMATOLOGY QUALITY CONTROL MIXTURE | Fisher Scientific Co., LLC | 1983-02-01 |
| K771588 | PLATELET CONTROLS NORMAL & ABNORMAL | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-25 |
| K770655 | LATELET DETERMIBATION KIT, UL 800 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-06-24 |
Legacy Summary#
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FDA Review#
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