510(k) K823930
- Device
- HEMATOLOGY QUALITY CONTROL MIXTURE
- Applicant
- FISHER SCIENTIFIC CO., LLC.
- 510(k) number
- K823930
- Product code
- GJP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-02-01
- Date received
- 1982-12-29
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
|---|---|---|---|
| K880608 | MSI-PC | Medical Specialties, Inc. | 1988-03-21 |
| 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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases