Product code JCN
- Device name
- Control, Cell Counter, Normal And Abnormal
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.8625
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K902389 | TRI-COUNT 16 | Hematronix, Inc. | 1990-08-22 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00815762020490 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2025-12-01 |
| 30844509000199 | Para 12® Plus | STRECK, INC. | 2020-08-24 |
| B787OCK10 | OLO Control Kit | S.D. SIGHT DIAGNOSTICS LTD | 2020-05-04 |
| 00815762021978 | R & D Systems, Inc. CBC-PIX Hematology Control | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2018-12-05 |
| 00630414473413 | ADVIA® 120/2120/2120i 3-in-1 TESTpoint High Control | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414473406 | ADVIA® 120/2120/2120i 3-in-1 TESTpoint Low Control | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414473390 | ADVIA® 120/2120/2120i 3-in-1 TESTpoint Normal Control | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414224404 | ADVIA® 120/2120/2120i TESTpoint High Control | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414224381 | ADVIA® 120/2120/2120i TESTpoint Normal Control | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414224367 | ADVIA® 120/2120/2120i TESTpoint Low Control | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00844509001188 | STaK-Chex | STRECK, INC. | 2016-09-19 |
| 00844509001171 | STaK-Chex | STRECK, INC. | 2016-09-19 |
| 20844509001144 | STaK-Chex | STRECK, INC. | 2016-09-19 |
| 20844509001151 | STaK-Chex | STRECK, INC. | 2016-09-19 |
| 20844509001168 | STaK-Chex | STRECK, INC. | 2016-09-19 |
| 30844509001158 | STaK-Chex | STRECK, INC. | 2016-09-19 |
| 00844509000228 | Para 12 Plus | STRECK, INC. | 2016-09-14 |
| 20844509000185 | Para 12 Plus | STRECK, INC. | 2016-09-14 |
| 20844509000192 | Para 12 Plus | STRECK, INC. | 2016-09-14 |
| 20844509000208 | Para 12 Plus | STRECK, INC. | 2016-09-14 |
| 00844509000211 | Para 12 Plus | STRECK, INC. | 2016-09-14 |
| 00844509000235 | Para 12 Plus | STRECK, INC. | 2016-09-14 |
| 00847661003007 | Liquichek | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847661002994 | Liquichek | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847661002987 | Liquichek | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847661002970 | Liquichek | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847661002963 | Liquichek | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00380740017101 | CELL-DYN | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740017118 | CELL-DYN | ABBOTT LABORATORIES | 2016-06-06 |