Platelet Counting Kit
FDA 510(k) K802636 · Streck Laboratories, Inc.
510(k) numberK802636
Submission
- Device name
- Platelet Counting Kit
- Applicant
- Streck Laboratories, Inc.
Mchenry, IL, US - Received
- October 23, 1980
- Decision date
- December 11, 1980
- 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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| K050235 | Iq 200 Urine Analyzer Body Fluids ModuleGKL · Traditional | Iris International, Inc. | 03/23/2005SE |
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| K022331 | Advia 120 Hematology System, Cerebrospinal Fluid MethodGKL · Special | Bayer Diagnostics Corp. | 09/11/2002SE |
| K001683 | Sysmex R-500GKL · Traditional | Sysmex Corporation of America | 08/21/2000SE |
| K991070 | Coulter Z2 AnalyzerGKL · Traditional | Coulter Corp. | 05/11/1999SE |
| K981950 | Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional | Sysmex Corp. | 11/03/1998SE |
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Questions and answers
When was Platelet Counting Kit cleared by the FDA?
Platelet Counting Kit (K802636) received a 510(k) decision of Substantially Equivalent on December 11, 1980, 49 days after the submission was received.
What is the product code of K802636?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.