QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)
FDA 510(k) K960827 · Becton Dickinson Diagnostic Instrument Systems
510(k) numberK960827
Submission
- Device name
- QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)
- Applicant
- Becton Dickinson Diagnostic Instrument Systems
Sparks, MD, US - Received
- February 29, 1996
- Decision date
- May 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKZ – Counter, Differential Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
Other 510(k)s with product code GKZ
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|---|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ · Traditional | Sysmex America, Inc. | 05/27/2026SE |
| K243348 | Athelas HomeGKZ · Traditional | Athelas, Inc. | 02/06/2026SE |
| K251249 | Tru Hematology TestGKZ · Traditional | Truvian Sciences, Inc. | 01/16/2026SE |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 06/25/2025SE |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 06/25/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | Abbott Laboratories | 02/20/2025SE |
| K240402 | Cito CBC SystemGKZ · Dual Track | Cytochip, Inc. | 02/03/2025SE |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…GKZ · Traditional | Beckman Coulter, Inc. | 07/05/2024SE |
| K232946 | Yumizen H2500GKZ · Traditional | Horiba Abx SAS | 05/21/2024SE |
| K240636 | HemoScreen Hematology AnalyzerGKZ · Abbreviated | Pixcell Medical Technologies | 05/02/2024SE |
More from Pixcell Medical Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K954923 | Bactec Fungal MediumJTA · Traditional | 11/21/1996SE |
| K954932 | BBL Mgit ProductsMDB · Traditional | 08/21/1996SE |
| K962210 | Bactec 9050 SystemMDB · Traditional | 08/08/1996SE |
| K946268 | Bactec(R) 9000TB SystemMDB · Traditional | 05/21/1996SE |
| K954930 | Bactec Culture Vials, Lytic, AnaerobicMDB · Traditional | 02/16/1996SE |
| K954927 | Bactec Peds Plus/F Culture VialsMDB · Traditional | 02/16/1996SE |
| K954925 | Bactec LYTIC/10 Anaerobic/F Culture VialsMDB · Traditional | 02/16/1996SE |
| K954921 | Bactec STANDARD/10 Aerobic/F Culture VialsMDB · Traditional | 02/16/1996SE |
| K954924 | Bactec Peds Plus Cluture VialsMDB · Traditional | 02/08/1996SE |
| K955504 | QBC Accuread SystemGKZ · Traditional | 02/05/1996SE |
Questions and answers
When was QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) cleared by the FDA?
QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) (K960827) received a 510(k) decision of Substantially Equivalent on May 17, 1996, 78 days after the submission was received.
What is the product code of K960827?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.