Atlas FDA

GIF

38 FDA 510(k) clearances · Product code

40 daysmedian time to decision
94 days90th percentile
38clearances measured

FDA profile

Official device name
Diluent, Blood Cell
Device class
Class I (low risk)
Regulation
21 CFR 864.8200
Medical specialty
Hematology
Adverse events (MAUDE)
1994: 1 · 1997: 1 · 2006: 5 · 2011: 6 · 2014: 125
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
KVM ISOTONIC FLUSH SOLUTION (K883989)Kvm Technologies, Inc.1988-10-12
KVM ISOTONIC DILUENT (K883990)Kvm Technologies, Inc.1988-10-12
HYCEL QUICK-LYSING HEMOGLOBIN REAGENT (K882490)R&D Systems, Inc.1988-07-25
SYSMEX QUICKLYSER-II (QLS-200A) (K882267)Toa Medical Electronics USA, Inc.1988-07-12
CELL-DYN ISOTONIC DILUENT (K881130)Abbott Diagnostics1988-03-31
CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (K873347)Abbott Diagnostics1987-09-09
OSMOCEL 3 (K851843)Hematology Marketing Assoc.1985-07-30
SDI PREPAX DILUKIT M. (K851320)Scientific Distributors, Inc.1985-07-05
DASS PACK (K851280)Dass, Inc.1985-07-05
SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- (K850239)Toa Medical Electronics USA, Inc.1985-04-01
LASER-DIL (K850095)Hematology Marketing Assoc.1985-03-29
NSI ELT-D DILUTING FLUID 4000ML (K844782)Nobel Scientific Industries, Inc.1985-03-05
HAYEM DILUTING FLUID (K842929)E K Ind., Inc.1984-09-07
IDI ISOTONIC DILUENT (K842068)Interscience Diagnostics, Inc.1984-07-02
CYANOMETHEMOGLOBIN REAGENT (K841799)Reagent Laboratory, Inc.1984-05-31
UNITIZED HEMATOLOGY SET 65132/93 (K840477)Emd Chemicals, Inc.1984-03-05
SDI PREPAX DILUKIT HW (K840041)Scientific Distributors, Inc.1984-03-05
QUICK-COUNT HEMATOLOGY REAGENT KIT (K833972)Seragen Diagnostics, Inc.1984-02-17
PREPAX DILUKIT PLUS (K840038)Scientific Distributors, Inc.1984-02-10
SDI PREPAX DILUKIT CT (K840043)Scientific Distributors, Inc.1984-02-10
ISOTONIC BLOOD CELL DILUENT J & S (K833443)Jasins & Sayles Associates, Inc.1983-11-03
ATAC 4700 HEMATOLOGY CELL COUNTER (K832116)Turpen Laboratory Systems, Inc.1983-10-20
DILUENT (K831617)Omega Medical Diagnostics1983-06-16
OSMOCEL + (K830188)Hematology Marketing Assoc.1983-03-01
BLOOD CELL DILUENT 78N 1913 (K822325)Interscience, Inc.1982-10-18
CDL ISOTONIC DILUENT (K822501)Connecticut Diagnostics, Ltd.1982-09-17
REAGENT FOR COULTER COUNTER MODEL 5+11 (K821683)Fisher Scientific Co., LLC1982-06-24
CRYOSAN NORMAL SALINE (K812309)Cryosan, Inc.1981-09-16
MODIFIED BLOOD CELL COUNTING & LYSING (K801357)Coulter Electronics, Inc.1980-08-14
NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA (K801346)Nobel Scientific Industries, Inc.1980-08-12
VARIOUS REAGENTS FOR BLOOD CELL ANALYZER (K800180)Laboratory Products, Inc.1980-03-19
ISOTONIC DILUENT (K790442)Royco Instruments1979-04-04
DILUENT, CELLENT BLOOD (K790028)Sysmex Corp.1979-02-15
ISOTONIC DILUENT (K781008)Mallinckrodt Critical Care1978-06-28
ISOTONIC BUFFERED SALINE (K780830)Harleco1978-06-14
AZIDE FREE BLOOD DILUTING REAGENT (K771787)J.T. Baker Chemical Co.1977-10-07
SALINE, ISOTONIC BUFFERED, AZIDE-FREE (K760129)Harleco1976-07-20
AUTO CELL DILUENT (K760124)Bd Becton Dickinson Vacutainer Systems Preanalytic1976-07-20

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