510(k) K902389
- Device
- TRI-COUNT 16
- Applicant
- HEMATRONIX, INC.
- 510(k) number
- K902389
- Product code
- JCN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-08-22
- Date received
- 1990-05-30
- Regulation
- 864.8625
- Classification name
- Control, Cell Counter, Normal And Abnormal
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES D LAPICOLA
- Address
- 1505 Capital Ave. Plano TX US 75074 75074
FDA Registration Numbers#
- 3010127294
- 3014150341
- 2016706
- 3038625004
- 2182501
- 1950302
- 3042989733
- 3002821232
- 3005333358
- 2432235
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JCN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993825 | PARA TECH PLUS RETICS | Streck Laboratories, Inc. | 1999-11-30 |
| K942209 | LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH | Bio-Rad | 1994-06-16 |
| K934497 | CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1993-12-06 |
| K911582 | STAK-CHEX | Streck Laboratories, Inc. | 1991-05-28 |
| K902391 | CELL-DYN 3000 CONTROL | Unipath , Ltd. | 1990-08-22 |
| K901875 | PARA 12 PLUS | Streck Laboratories, Inc. | 1990-05-30 |
| K896154 | PARA TECH FOR TECHNICON H-1 | Streck Laboratories, Inc. | 1989-11-09 |
| K895373 | HEMATOLOGY CONTROL | Medical Specialties Intl., Inc. | 1989-10-06 |
| K891907 | QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED | R&D Systems, Inc. | 1989-04-11 |
| K874386 | CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1987-12-30 |
| K821956 | HAEM-C PLUS BLOOD REFERENCE CONTROLS | Baker Instructions Corp. | 1982-07-30 |
Legacy Summary#
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FDA Review#
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