Prepax Dilukit Plus
FDA 510(k) K840038 · Scientific Distributors, Inc.
510(k) numberK840038
Submission
- Device name
- Prepax Dilukit Plus
- Applicant
- Scientific Distributors, Inc.
Mchenry, IL, US - Received
- January 5, 1984
- Decision date
- February 10, 1984
- 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 |
| 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 |
More from Toa Medical Electronics USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K892658 | Sdi Prepax Countapette KitJCG · Traditional | 05/24/1989SE |
| K851320 | Sdi Prepax Dilukit M.GIF · Traditional | 07/05/1985SE |
| K840044 | Sdi Prepax Dilukit 29-1000JJO · Traditional | 03/09/1984SE |
| K840041 | Sdi Prepax Dilukit HWGIF · Traditional | 03/05/1984SE |
| K840043 | Sdi Prepax Dilukit CTGIF · Traditional | 02/10/1984SE |
| K840042 | Sdi Prepax Dilukit Ca · Traditional | 02/10/1984SE |
Questions and answers
When was Prepax Dilukit Plus cleared by the FDA?
Prepax Dilukit Plus (K840038) received a 510(k) decision of Substantially Equivalent on February 10, 1984, 36 days after the submission was received.
What is the product code of K840038?
The FDA product code is GIF – Diluent, Blood Cell, a Class I (low risk) device regulated under 21 CFR 864.8200.