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Fisher Scientific Co., LLC · Predicate Candidate Screening

89 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

35 daysmedian FDA review time

72 days90th percentile

89clearances measured

K-number	Device	Applicant	Decided	Review days
K930415	MICROHEMATOCRIT ROTOR	Fisher Scientific Co., LLC	1993-03-23	56
K915825	MARATHON 6K GENERAL-PURPOSE CENTRIFUGE	Fisher Scientific Co., LLC	1992-03-11	72
K915441	MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE	Fisher Scientific Co., LLC	1992-01-08	35
K890534	MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1	Fisher Scientific Co., LLC	1989-03-08	41
K881275	URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II	Fisher Scientific Co., LLC	1988-05-16	52
K874054	FISHER DIAGNOSTICS HEMATALL III LAS REAGENT	Fisher Scientific Co., LLC	1987-10-20	15
K872916	HISTOMATIC SLIDE STAINER, CODE-ON VERSION	Fisher Scientific Co., LLC	1987-09-14	52
K871058	SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN)	Fisher Scientific Co., LLC	1987-04-06	20
K863224	HEMATALL-C PLUS HEMATOLOGY CONTROLS	Fisher Scientific Co., LLC	1986-10-29	69
K862318	FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR	Fisher Scientific Co., LLC	1986-07-10	22
K861185	THERACHEM-PLUS, TRI-LEVEL TDC (TM)	Fisher Scientific Co., LLC	1986-05-23	53
K860919	THERACHEM, TDC THERAPEUTIC DRUG CONTROLS	Fisher Scientific Co., LLC	1986-04-11	31
K853241	HEMATOLOGY STAIN PACK	Fisher Scientific Co., LLC	1985-08-19	18
K851151	FISHER DIAGNOSTICS KDA CALIBRATOR II	Fisher Scientific Co., LLC	1985-05-20	60
K851150	FISHER DIAGNOSTICS KDA CALIBRATOR I	Fisher Scientific Co., LLC	1985-05-20	60
K850636	SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E	Fisher Scientific Co., LLC	1985-03-20	29
K844168	AMYLASE REAGENT CS-726	Fisher Scientific Co., LLC	1984-11-20	26
K843452	STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ	Fisher Scientific Co., LLC	1984-09-27	22
K840111	TOTAL BILIRUBIN	Fisher Scientific Co., LLC	1984-03-19	69
K833712	NA/K FLUIDA PACK FOR NOVA 1 ANALYZER	Fisher Scientific Co., LLC	1984-01-13	84
K833950	TOTAL PROTEIN REAGENT CS-724	Fisher Scientific Co., LLC	1984-01-13	59
K833699	ALBUMIN REAGENT CS-716	Fisher Scientific Co., LLC	1984-01-13	87
K833035	CALCIUM DYE REAGENT-CS-718-A/BUFFER	Fisher Scientific Co., LLC	1983-11-03	57
K832879	B-SLIDE PREGNATE PREGNANCY TEST KIT	Fisher Scientific Co., LLC	1983-10-28	63
K831019	PH 6.838 REF. BUFFER	Fisher Scientific Co., LLC	1983-06-16	78
K831024	ELECTROLYTE PO2 FOR OXYGEN ELECTRODES	Fisher Scientific Co., LLC	1983-06-16	78
K831021	CALIBRATING SOLUTION FOR ABL-1 & 2	Fisher Scientific Co., LLC	1983-06-16	78
K831018	CALIBRATING SOLUTION FOR ABL-1 & 2	Fisher Scientific Co., LLC	1983-06-16	78
K831025	ELECTROLYLE CARBON DIOXIDE ELECTRODES	Fisher Scientific Co., LLC	1983-06-16	78
K831023	REFERENCE BUFFER PH 7.382	Fisher Scientific Co., LLC	1983-06-15	77
K831013	DIAGNOSTICS PO 2 ELECTROLYTE	Fisher Scientific Co., LLC	1983-06-08	70
K831012	DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON	Fisher Scientific Co., LLC	1983-06-08	70
K831015	DIAGNOSTICS PH ELECTRODE CLEANING SOLUT	Fisher Scientific Co., LLC	1983-05-25	56
K831017	BUFFER PACK FOR ABL-1 & ABL-2	Fisher Scientific Co., LLC	1983-05-09	40
K831020	FLUSH SOLUTION CONCENTRATE	Fisher Scientific Co., LLC	1983-05-09	40
K831010	DIAGNOSTICS PO2 ELECTRODE CLEANER	Fisher Scientific Co., LLC	1983-05-05	36
K831016	BATH CLEAR	Fisher Scientific Co., LLC	1983-05-05	36
K830578	MICROHEMATOCRIT READER	Fisher Scientific Co., LLC	1983-03-24	29
K830217	REAGENTS CORNING CHLORIDE METER FOR	Fisher Scientific Co., LLC	1983-02-18	25
K823930	HEMATOLOGY QUALITY CONTROL MIXTURE	Fisher Scientific Co., LLC	1983-02-01	34
K823929	MULTIANALYTE CONTROLS-ALL KINDS	Fisher Scientific Co., LLC	1983-01-28	30
K823558	MICRO-HEMATOCRIT CENTRIFUGE 335/336	Fisher Scientific Co., LLC	1983-01-21	50
K822905	LATEST RF KIT FOR RHEUMATOID FACTOR	Fisher Scientific Co., LLC	1982-10-18	19
K822496	SERA CHEM SMAC CALIBRATORS	Fisher Scientific Co., LLC	1982-09-21	34
K822352	HEMATOXYLIN STAIN SOLUTION	Fisher Scientific Co., LLC	1982-08-16	10
K821683	REAGENT FOR COULTER COUNTER MODEL 5+11	Fisher Scientific Co., LLC	1982-06-24	16
K820731	HEMATALL-C PLUS HEMATOLOGY CONTROLS	Fisher Scientific Co., LLC	1982-05-12	56
K820996	SALMONELLA & SHIGELLA GROUPING SERA	Fisher Scientific Co., LLC	1982-05-03	24
K813505	FLAME PHOTOMETER CALIBRATION STANDARDS	Fisher Scientific Co., LLC	1981-12-31	16
K812623	CLEANING SOLUTION FOR RADIOMETER OSM2	Fisher Scientific Co., LLC	1981-11-02	48

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda