GKZClass II
Counter, Differential Cell
21 CFR 864.5220 / Hematology
GKZ is the FDA product code for Counter, Differential Cell, a class II device type, regulated under 21 CFR 864.5220. As of , FDA records hold 380 510(k) clearances under this code, the most recent dated , and 244 recalls.
Classification record
- Product code
- GKZ
- Device name
- Counter, Differential Cell
- Regulation
- 21 CFR 864.5220
- Device class
- Class II
- Review panel
- Hematology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 381
- Ingested recalls
- 244
Clearances, product code GKZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 7 |
| 1978 | 1 |
| 1979 | 5 |
| 1980 | 2 |
| 1981 | 1 |
| 1982 | 2 |
| 1983 | 1 |
| 1984 | 5 |
| 1985 | 5 |
| 1986 | 7 |
| 1987 | 7 |
| 1988 | 17 |
| 1989 | 12 |
| 1990 | 12 |
| 1991 | 15 |
| 1992 | 13 |
| 1993 | 14 |
| 1994 | 8 |
| 1995 | 35 |
| 1996 | 33 |
| 1997 | 21 |
| 1998 | 13 |
| 1999 | 14 |
| 2000 | 5 |
| 2001 | 6 |
| 2002 | 6 |
| 2003 | 14 |
| 2004 | 9 |
| 2005 | 13 |
| 2006 | 9 |
| 2007 | 6 |
| 2008 | 6 |
| 2009 | 6 |
| 2010 | 4 |
| 2011 | 3 |
| 2012 | 3 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 3 |
| 2016 | 3 |
| 2017 | 4 |
| 2018 | 3 |
| 2019 | 5 |
| 2020 | 1 |
| 2022 | 3 |
| 2023 | 4 |
| 2024 | 3 |
| 2025 | 4 |
| 2026 | 4 |
Applicants with the most clearances
Product code GKZ| Applicant | Clearances |
|---|---|
| Siemens Healthcare Diagnostics Inc. | 31 |
| Abbott Medical | 24 |
| Coulter Corp. | 23 |
| Sysmex America, Inc. | 22 |
| Becton Dickinson Immunocytometry Systems | 21 |
| Ortho Diagnostic Systems, Inc. | 16 |
| BD Becton Dickinson Vacutainer Systems Preanalytic | 15 |
| Coulter Electronics, Inc. | 14 |
| Coulter Immunology | 14 |
| Dako Corp. | 14 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Laboratories (Singapore) Private Limited
- Abbott Medical
- Agilent Technologies Denmark ApS
- Agilent Technologies Singapore (International) Pte Ltd.
- Agilent Technologies, Inc.
- Alius Scientific,LLC
- Antibodies Incorporated
- Arkray Factory USA, Inc.
- Athelas
- ATSI Logistics Center ApS
- Beckman Coulter Distribution B.V.
- Becton Dickinson Caribe, Ltd
FIRST ARTICLE / WEEKLY
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