Counter 700 & HC-700 Hemo 0 Ref.
FDA 510(k) K771107 · Hycel, Inc.
510(k) numberK771107
Submission
- Device name
- Counter 700 & HC-700 Hemo 0 Ref.
- Applicant
- Hycel, Inc.
Mchenry, IL, US - Received
- June 20, 1977
- Decision date
- July 11, 1977
- 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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|---|---|---|---|
| K152776 | Glocyte Automated Cell Counter SystemGKL · Traditional | Advanced Instruments, Inc. | 05/27/2016SE |
| K091539 | Iq 200 Urine Analizer Body Fluids ModuleGKL · Traditional | Iris Diagnostics | 08/31/2010SE |
| K071652 | Hemocue WBC SystemGKL · Traditional | Hemocue AB | 10/25/2007SE |
| K051693 | Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide SystemGKL · Traditional | Bayer Healthcare, LLC | 12/07/2005SE |
| K050235 | Iq 200 Urine Analyzer Body Fluids ModuleGKL · Traditional | Iris International, Inc. | 03/23/2005SE |
| K032677 | Sysmex POCH-100IGKL · Traditional | Sysmex America, Inc. | 02/11/2004SE |
| 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 |
More from Sysmex Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K802422 | Hycel Trigyceride II Test · Traditional | 10/06/1980SESP |
| K790335 | Hycel MJJF · Traditional | 02/27/1979SE |
| K782176 | Hycel Ldh-Int TestCFH · Traditional | 01/26/1979SE |
| K782116 | Ketosteroid Test, HYCEL-17CCY · Traditional | 01/26/1979SE |
| K782102 | Hycel Counter 211GKL · Traditional | 01/03/1979SE |
| K782101 | Hycel Counter 222GKL · Traditional | 01/03/1979SE |
| K782100 | Hycel Counter 333GKL · Traditional | 01/03/1979SE |
| K781004 | Hma Uric Acid TestKNK · Traditional | 07/27/1978SE |
| K780946 | Royco Model 970 Hematology Data AnalyzerJPJ · Traditional | 07/27/1978SE |
| K780464 | Lelective Kinetic SYSTEM-60JJE · Traditional | 05/03/1978SE |
Questions and answers
When was Counter 700 & HC-700 Hemo 0 Ref. cleared by the FDA?
Counter 700 & HC-700 Hemo 0 Ref. (K771107) received a 510(k) decision of Substantially Equivalent on July 11, 1977, 21 days after the submission was received.
What is the product code of K771107?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.