510(k) K831558
- Device
- E-Z PREP
- Applicant
- COULTER ELECTRONICS, INC.
- 510(k) number
- K831558
- Product code
- GKJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-06-16
- Date received
- 1983-05-16
- Regulation
- 864.5850
- Classification name
- Spinner, Slide, Automated
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8020030
- 3009000266
- 3003630693
- 2531191
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GKJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K854962 | MICRO-MAT SYSTEM | Ulster Scientific, Inc. | 1985-12-23 |
| K854121 | MICRO-MAT SYSTEM | Prevo Micro-Mat System | 1985-10-31 |
| K811534 | HEMASPINNER | Geometric Data, Div. Smithkline Corp. | 1981-08-18 |
| K771898 | AUTOMATED SLIDE SPINNER | Dynatech Cryomedical Co. | 1977-10-18 |
| K760007 | BLOOD-SMEARING INSTRUMENT (MINIPREP TM) | Geometric Data, Div. Smithkline Corp. | 1976-09-03 |
Legacy Summary#
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FDA Review#
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