Sysmex Quicklyser-Ii (QLS-200A)
FDA 510(k) K882267 · Toa Medical Electronics USA, Inc.
510(k) numberK882267
Submission
- Device name
- Sysmex Quicklyser-Ii (QLS-200A)
- Applicant
- Toa Medical Electronics USA, Inc.
Los Alamitos, CA, US - Received
- May 31, 1988
- Decision date
- July 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GIF – Diluent, Blood Cell
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8200
- Specialty
- Hematology
Other 510(k)s with product code GIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883990 | KVM Isotonic DiluentGIF · Traditional | Kvm Technologies, Inc. | 10/12/1988SE |
| K883989 | KVM Isotonic Flush SolutionGIF · Traditional | Kvm Technologies, Inc. | 10/12/1988SE |
| K882490 | Hycel Quick-Lysing Hemoglobin ReagentGIF · Traditional | R&D Systems, Inc. | 07/25/1988SE |
| K881130 | Cell-Dyn Isotonic DiluentGIF · Traditional | Abbott Diagnostics | 03/31/1988SE |
| K873347 | Cell-Dyn Diff. Screen Isotonic DiluentGIF · Traditional | Abbott Diagnostics | 09/09/1987SE |
| K851843 | Osmocel 3GIF · Traditional | Hematology Marketing Assoc. | 07/30/1985SE |
| K851320 | Sdi Prepax Dilukit M.GIF · Traditional | Scientific Distributors, Inc. | 07/05/1985SE |
| K851280 | Dass PackGIF · Traditional | Dass, Inc. | 07/05/1985SE |
| K850239 | Sysmex Hematological Whole Blood Diluting Reagent-GIF · Traditional | Toa Medical Electronics USA, Inc. | 04/01/1985SE |
| K850095 | Laser-DilGIF · Traditional | Hematology Marketing Assoc. | 03/29/1985SE |
More from Hematology Marketing Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K936023 | Sysmex SE-9000 Automated Hematology AnalyzerGKZ · Traditional | 05/02/1994SE |
| K933886 | Toa Medical Electronics CA-5000JPA · Traditional | 01/27/1994SE |
| K931149 | CA-1000 Automated Coagulation AnalyzerJPA · Traditional | 11/03/1993SE |
| K920544 | Sysmex Hematology System AccessoriesGKZ · Traditional | 04/29/1992SE |
| K914744 | Sysmex NE-1500, ModificationGKZ · Traditional | 12/30/1991SE |
| K912494 | Sysmex(Tm) R-3000 Automated Reticulocyte AnalyzerGKL · Traditional | 09/10/1991SE |
| K911173 | Sysmex F-310GKL · Traditional | 07/26/1991SE |
| K911172 | Sysmex F-610GKL · Traditional | 07/26/1991SE |
| K910849 | Sysmex F-810GKL · Traditional | 07/26/1991SE |
| K910745 | Hemoglobin ReagentGKR · Traditional | 07/11/1991SE |
Questions and answers
When was Sysmex Quicklyser-Ii (QLS-200A) cleared by the FDA?
Sysmex Quicklyser-Ii (QLS-200A) (K882267) received a 510(k) decision of Substantially Equivalent on July 12, 1988, 42 days after the submission was received.
What is the product code of K882267?
The FDA product code is GIF – Diluent, Blood Cell, a Class I (low risk) device regulated under 21 CFR 864.8200.