Technicon H6000 System
FDA 510(k) K832627 · Technicon Instruments Corp.
510(k) numberK832627
Submission
- Device name
- Technicon H6000 System
- Applicant
- Technicon Instruments Corp.
Mchenry, IL, US - Received
- August 4, 1983
- Decision date
- September 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKL – Counter, Cell, Automated (Particle Counter)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5200
- Specialty
- Hematology
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Questions and answers
When was Technicon H6000 System cleared by the FDA?
Technicon H6000 System (K832627) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 39 days after the submission was received.
What is the product code of K832627?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.