KVM Isotonic Flush Solution
FDA 510(k) K883989 · Kvm Technologies, Inc.
510(k) numberK883989
Submission
- Device name
- KVM Isotonic Flush Solution
- Applicant
- Kvm Technologies, Inc.
Houston, TX, US - Received
- September 20, 1988
- Decision date
- October 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 |
| K882490 | Hycel Quick-Lysing Hemoglobin ReagentGIF · Traditional | R&D Systems, Inc. | 07/25/1988SE |
| K882267 | Sysmex Quicklyser-Ii (QLS-200A)GIF · Traditional | Toa Medical Electronics USA, Inc. | 07/12/1988SE |
| 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.
Questions and answers
When was KVM Isotonic Flush Solution cleared by the FDA?
KVM Isotonic Flush Solution (K883989) received a 510(k) decision of Substantially Equivalent on October 12, 1988, 22 days after the submission was received.
What is the product code of K883989?
The FDA product code is GIF – Diluent, Blood Cell, a Class I (low risk) device regulated under 21 CFR 864.8200.