GIF · Diluent, Blood Cell
Hematology · 21 CFR 864.8200 · Class 1
Overview
| Product Code | GIF |
|---|---|
| Device Name | Diluent, Blood Cell |
| Regulation | 21 CFR 864.8200 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
Classification Rationale
Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (20 of 38)
Showing 20 most recent of 38 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K883990 | KVM ISOTONIC DILUENT | Kvm Technologies, Inc. | Oct 12, 1988 | SESE |
| K883989 | KVM ISOTONIC FLUSH SOLUTION | Kvm Technologies, Inc. | Oct 12, 1988 | SESE |
| K882490 | HYCEL QUICK-LYSING HEMOGLOBIN REAGENT | R&D Systems, Inc. | Jul 25, 1988 | SESE |
| K882267 | SYSMEX QUICKLYSER-II (QLS-200A) | Toa Medical Electronics USA, Inc. | Jul 12, 1988 | SESE |
| K881130 | CELL-DYN ISOTONIC DILUENT | Abbott Diagnostics | Mar 31, 1988 | SESE |
| K873347 | CELL-DYN DIFF. SCREEN ISOTONIC DILUENT | Abbott Diagnostics | Sep 9, 1987 | SESE |
| K851843 | OSMOCEL 3 | Hematology Marketing Assoc. | Jul 30, 1985 | SESE |
| K851320 | SDI PREPAX DILUKIT M. | Scientific Distributors, Inc. | Jul 5, 1985 | SESE |
| K851280 | DASS PACK | Dass, Inc. | Jul 5, 1985 | SESE |
| K850239 | SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- | Toa Medical Electronics USA, Inc. | Apr 1, 1985 | SESE |
| K850095 | LASER-DIL | Hematology Marketing Assoc. | Mar 29, 1985 | SESE |
| K844782 | NSI ELT-D DILUTING FLUID 4000ML | Nobel Scientific Industries, Inc. | Mar 5, 1985 | SESE |
| K842929 | HAYEM DILUTING FLUID | E K Ind., Inc. | Sep 7, 1984 | SESE |
| K842068 | IDI ISOTONIC DILUENT | Interscience Diagnostics, Inc. | Jul 2, 1984 | SESE |
| K841799 | CYANOMETHEMOGLOBIN REAGENT | Reagent Laboratory, Inc. | May 31, 1984 | SESE |
| K840477 | UNITIZED HEMATOLOGY SET 65132/93 | Emd Chemicals, Inc. | Mar 5, 1984 | SESE |
| K840041 | SDI PREPAX DILUKIT HW | Scientific Distributors, Inc. | Mar 5, 1984 | SESE |
| K833972 | QUICK-COUNT HEMATOLOGY REAGENT KIT | Seragen Diagnostics, Inc. | Feb 17, 1984 | SESE |
| K840043 | SDI PREPAX DILUKIT CT | Scientific Distributors, Inc. | Feb 10, 1984 | SESE |
| K840038 | PREPAX DILUKIT PLUS | Scientific Distributors, Inc. | Feb 10, 1984 | SESE |
Top Applicants
- Scientific Distributors, Inc. — 4 clearances
- Hematology Marketing Assoc. — 3 clearances
- Abbott Diagnostics — 2 clearances
- Harleco — 2 clearances
- Kvm Technologies, Inc. — 2 clearances
