Quick-Count Plus 2
FDA 510(k) K841504 · Seragen Diagnostics, Inc.
510(k) numberK841504
Submission
- Device name
- Quick-Count Plus 2
- Applicant
- Seragen Diagnostics, Inc.
Mchenry, IL, US - Received
- April 10, 1984
- Decision date
- June 11, 1984
- 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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More from Sysmex Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K872148 | Vivid Chlamydia(Tm)LJC · Traditional | 08/19/1987SE |
| K851663 | Quick-Count Hematology ControlsJPK · Traditional | 07/23/1985SE |
| K852260 | Quick-Chem Calibration SetJIW · Traditional | 07/22/1985SE |
| K851520 | Ck/Ld Isoenzymes Controls(Human)JJT · Traditional | 06/25/1985SE |
| K851521 | LD-1(IMMUNO) Separation SetCEX · Traditional | 05/10/1985SE |
| K850209 | Quick-LyteJGS · Traditional | 02/27/1985SE |
| K844743 | Seratest Ena(Rnp/Sm) DeterminationLLL · Traditional | 02/04/1985SE |
| K842563 | Seratest DNA DeterminationLKJ · Traditional | 10/25/1984SE |
| K840793 | Ck/Mb Immuno-Isoenzyme Control SerumJJT · Traditional | 04/13/1984SE |
| K840863 | Seratest RF Latex DeterminationDHR · Traditional | 04/04/1984SE |
Questions and answers
When was Quick-Count Plus 2 cleared by the FDA?
Quick-Count Plus 2 (K841504) received a 510(k) decision of Substantially Equivalent on June 11, 1984, 62 days after the submission was received.
What is the product code of K841504?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.