Panels › Hematology › Product code GIF · Class 1
Diluent, Blood Cell
Regulation 864.8200
0510(k)s in 12 months (38 all time)
1recalls in 12 months (13 all time)
8recalls that name a 510(k)
Top companies in GIF
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 12, 1988 | K883990 | KVM ISOTONIC DILUENT Kvm Technologies, Inc. | GIF |
| Oct 12, 1988 | K883989 | KVM ISOTONIC FLUSH SOLUTION Kvm Technologies, Inc. | GIF |
| Jul 25, 1988 | K882490 | HYCEL QUICK-LYSING HEMOGLOBIN REAGENT R&D Systems, Inc. | GIF |
| Jul 12, 1988 | K882267 | SYSMEX QUICKLYSER-II (QLS-200A) Toa Medical Electronics USA, Inc. | GIF |
| Mar 31, 1988 | K881130 | CELL-DYN ISOTONIC DILUENT Abbott Diagnostics | GIF |
| Sep 9, 1987 | K873347 | CELL-DYN DIFF. SCREEN ISOTONIC DILUENT Abbott Diagnostics | GIF |
| Jul 30, 1985 | K851843 | OSMOCEL 3 Hematology Marketing Assoc. | GIF |
| Jul 5, 1985 | K851320 | SDI PREPAX DILUKIT M. Scientific Distributors, Inc. | GIF |
| Jul 5, 1985 | K851280 | DASS PACK Dass, Inc. | GIF |
| Apr 1, 1985 | K850239 | SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- Toa Medical Electronics USA, Inc. | GIF |
| Mar 29, 1985 | K850095 | LASER-DIL Hematology Marketing Assoc. | GIF |
| Mar 5, 1985 | K844782 | NSI ELT-D DILUTING FLUID 4000ML Nobel Scientific Industries, Inc. | GIF |
| Sep 7, 1984 | K842929 | HAYEM DILUTING FLUID E K Ind., Inc. | GIF |
| Jul 2, 1984 | K842068 | IDI ISOTONIC DILUENT Interscience Diagnostics, Inc. | GIF |
| May 31, 1984 | K841799 | CYANOMETHEMOGLOBIN REAGENT Reagent Laboratory, Inc. | GIF |
| Mar 5, 1984 | K840477 | UNITIZED HEMATOLOGY SET 65132/93 Emd Chemicals, Inc. | GIF |
| Mar 5, 1984 | K840041 | SDI PREPAX DILUKIT HW Scientific Distributors, Inc. | GIF |
| Feb 17, 1984 | K833972 | QUICK-COUNT HEMATOLOGY REAGENT KIT Seragen Diagnostics, Inc. | GIF |
| Feb 10, 1984 | K840043 | SDI PREPAX DILUKIT CT Scientific Distributors, Inc. | GIF |
| Feb 10, 1984 | K840038 | PREPAX DILUKIT PLUS Scientific Distributors, Inc. | GIF |
| Nov 3, 1983 | K833443 | ISOTONIC BLOOD CELL DILUENT J & S Jasins & Sayles Associates, Inc. | GIF |
| Oct 20, 1983 | K832116 | ATAC 4700 HEMATOLOGY CELL COUNTER Turpen Laboratory Systems, Inc. | GIF |
| Jun 16, 1983 | K831617 | DILUENT Omega Medical Diagnostics | GIF |
| Mar 1, 1983 | K830188 | OSMOCEL + Hematology Marketing Assoc. | GIF |
| Oct 18, 1982 | K822325 | BLOOD CELL DILUENT 78N 1913 Interscience, Inc. | GIF |
| Sep 17, 1982 | K822501 | CDL ISOTONIC DILUENT Connecticut Diagnostics, Ltd. | GIF |
| Jun 24, 1982 | K821683 | REAGENT FOR COULTER COUNTER MODEL 5+11 Fisher Scientific Co., LLC | GIF |
| Sep 16, 1981 | K812309 | CRYOSAN NORMAL SALINE Cryosan, Inc. | GIF |
| Aug 14, 1980 | K801357 | MODIFIED BLOOD CELL COUNTING & LYSING Coulter Electronics, Inc. | GIF |
| Aug 12, 1980 | K801346 | NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA Nobel Scientific Industries, Inc. | GIF |
| Mar 19, 1980 | K800180 | VARIOUS REAGENTS FOR BLOOD CELL ANALYZER Laboratory Products, Inc. | GIF |
| Apr 4, 1979 | K790442 | ISOTONIC DILUENT Royco Instruments | GIF |
| Feb 15, 1979 | K790028 | DILUENT, CELLENT BLOOD Sysmex Corp. | GIF |
| Jun 28, 1978 | K781008 | ISOTONIC DILUENT Mallinckrodt Critical Care | GIF |
| Jun 14, 1978 | K780830 | ISOTONIC BUFFERED SALINE Harleco | GIF |
| Oct 7, 1977 | K771787 | AZIDE FREE BLOOD DILUTING REAGENT J.T. Baker Chemical Co. | GIF |
| Jul 20, 1976 | K760129 | SALINE, ISOTONIC BUFFERED, AZIDE-FREE Harleco | GIF |
| Jul 20, 1976 | K760124 | AUTO CELL DILUENT Bd Becton Dickinson Vacutainer Systems Preanalytic | GIF |
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