Imagn(Tm) 2000 System
FDA 510(k) K945756 · Buckman Co., Inc.
510(k) numberK945756
Submission
- Device name
- Imagn(Tm) 2000 System
- Applicant
- Buckman Co., Inc.
Concord, CA, US - Received
- November 23, 1994
- Decision date
- December 19, 1995
- 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
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| K243283 | Alinity h-series SystemGKZ · Traditional | Abbott Laboratories | 02/20/2025SE |
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| K232946 | Yumizen H2500GKZ · Traditional | Horiba Abx SAS | 05/21/2024SE |
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Questions and answers
When was Imagn(Tm) 2000 System cleared by the FDA?
Imagn(Tm) 2000 System (K945756) received a 510(k) decision of Substantially Equivalent on December 19, 1995, 391 days after the submission was received.
What is the product code of K945756?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.