Panels › Hematology › Product code GKJ · Class 1
Spinner, Slide, Automated
Regulation 864.5850
0510(k)s in 12 months (6 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in GKJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Geometric Data, Div. Smithkline Corp. | 2 | 0 |
| Beckman Coulter Inc | 0 | 1 |
| Coulter Electronics, Inc. | 1 | 0 |
| Dynatech Cryomedical Co. | 1 | 0 |
| Prevo Micro-Mat System | 1 | 0 |
| Ulster Scientific, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 1985 | K854962 | MICRO-MAT SYSTEM Ulster Scientific, Inc. | GKJ |
| Oct 31, 1985 | K854121 | MICRO-MAT SYSTEM Prevo Micro-Mat System | GKJ |
| Jun 16, 1983 | K831558 | E-Z PREP Coulter Electronics, Inc. | GKJ |
| Aug 18, 1981 | K811534 | HEMASPINNER Geometric Data, Div. Smithkline Corp. | GKJ |
| Oct 18, 1977 | K771898 | AUTOMATED SLIDE SPINNER Dynatech Cryomedical Co. | GKJ |
| Sep 3, 1976 | K760007 | BLOOD-SMEARING INSTRUMENT (MINIPREP TM) Geometric Data, Div. Smithkline Corp. | GKJ |
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