Company ยท US
Fisher Scientific Co., LLC
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1993. Name variants (Inc, Corp, punctuation) are merged.
89510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 15 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 |
| JPK | Mixture, Hematology Quality Control | 5 |
| DIF | Drug Mixture Control Materials | 4 |
| JGS | Electrode, Ion Specific, Sodium | 3 |
| CEK | Biuret (Colorimetric), Total Protein | 2 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 |
| GKF | Instrument, Hematocrit, Automated | 2 |
| JFS | Coulometric, Chloride | 2 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 2 |
| JIT | Calibrator, Secondary | 2 |
| JIX | Calibrator, Multi-Analyte Mixture | 2 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 2 |
| JPI | Device, Hematocrit Measuring | 2 |
| JSC | Culture Media, General Nutrient Broth | 2 |
| KXG | Applicator, Absorbent Tipped, Sterile | 2 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 23, 1993 | K930415 | MICROHEMATOCRIT ROTOR Fisher Scientific Co., LLC | GKG |
| Mar 11, 1992 | K915825 | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE Fisher Scientific Co., LLC | GKF |
| Jan 8, 1992 | K915441 | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE Fisher Scientific Co., LLC | GKF |
| Mar 8, 1989 | K890534 | MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 Fisher Scientific Co., LLC | JJW |
| May 16, 1988 | K881275 | URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II Fisher Scientific Co., LLC | JJY |
| Oct 20, 1987 | K874054 | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT Fisher Scientific Co., LLC | GGK |
| Sep 14, 1987 | K872916 | HISTOMATIC SLIDE STAINER, CODE-ON VERSION Fisher Scientific Co., LLC | KPA |
| Apr 6, 1987 | K871058 | SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) Fisher Scientific Co., LLC | JJY |
| Oct 29, 1986 | K863224 | HEMATALL-C PLUS HEMATOLOGY CONTROLS Fisher Scientific Co., LLC | JPK |
| Jul 10, 1986 | K862318 | FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR Fisher Scientific Co., LLC | JPK |
| May 23, 1986 | K861185 | THERACHEM-PLUS, TRI-LEVEL TDC (TM) Fisher Scientific Co., LLC | JJY |
| Apr 11, 1986 | K860919 | THERACHEM, TDC THERAPEUTIC DRUG CONTROLS Fisher Scientific Co., LLC | DIF |
| Aug 19, 1985 | K853241 | HEMATOLOGY STAIN PACK Fisher Scientific Co., LLC | IAF |
| May 20, 1985 | K851151 | FISHER DIAGNOSTICS KDA CALIBRATOR II Fisher Scientific Co., LLC | JIX |
| May 20, 1985 | K851150 | FISHER DIAGNOSTICS KDA CALIBRATOR I Fisher Scientific Co., LLC | JIX |
| Mar 20, 1985 | K850636 | SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E Fisher Scientific Co., LLC | KDX |
| Nov 20, 1984 | K844168 | AMYLASE REAGENT CS-726 Fisher Scientific Co., LLC | CJA |
| Sep 27, 1984 | K843452 | STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ Fisher Scientific Co., LLC | JGS |
| Mar 19, 1984 | K840111 | TOTAL BILIRUBIN Fisher Scientific Co., LLC | CIG |
| Jan 13, 1984 | K833950 | TOTAL PROTEIN REAGENT CS-724 Fisher Scientific Co., LLC | CEK |
| Jan 13, 1984 | K833712 | NA/K FLUIDA PACK FOR NOVA 1 ANALYZER Fisher Scientific Co., LLC | JGS |
| Jan 13, 1984 | K833699 | ALBUMIN REAGENT CS-716 Fisher Scientific Co., LLC | CIX |
| Nov 3, 1983 | K833035 | CALCIUM DYE REAGENT-CS-718-A/BUFFER Fisher Scientific Co., LLC | CIC |
| Oct 28, 1983 | K832879 | B-SLIDE PREGNATE PREGNANCY TEST KIT Fisher Scientific Co., LLC | JHJ |
| Jun 16, 1983 | K831025 | ELECTROLYLE CARBON DIOXIDE ELECTRODES Fisher Scientific Co., LLC | CHL |
| Jun 16, 1983 | K831024 | ELECTROLYTE PO2 FOR OXYGEN ELECTRODES Fisher Scientific Co., LLC | CHL |
| Jun 16, 1983 | K831021 | CALIBRATING SOLUTION FOR ABL-1 & 2 Fisher Scientific Co., LLC | CHL |
| Jun 16, 1983 | K831019 | PH 6.838 REF. BUFFER Fisher Scientific Co., LLC | CHL |
| Jun 16, 1983 | K831018 | CALIBRATING SOLUTION FOR ABL-1 & 2 Fisher Scientific Co., LLC | CHL |
| Jun 15, 1983 | K831023 | REFERENCE BUFFER PH 7.382 Fisher Scientific Co., LLC | CHL |
| Jun 8, 1983 | K831013 | DIAGNOSTICS PO 2 ELECTROLYTE Fisher Scientific Co., LLC | CHL |
| Jun 8, 1983 | K831012 | DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON Fisher Scientific Co., LLC | CHL |
| May 25, 1983 | K831015 | DIAGNOSTICS PH ELECTRODE CLEANING SOLUT Fisher Scientific Co., LLC | CHL |
| May 9, 1983 | K831020 | FLUSH SOLUTION CONCENTRATE Fisher Scientific Co., LLC | CHL |
| May 9, 1983 | K831017 | BUFFER PACK FOR ABL-1 & ABL-2 Fisher Scientific Co., LLC | CHL |
| May 5, 1983 | K831016 | BATH CLEAR Fisher Scientific Co., LLC | CHL |
| May 5, 1983 | K831010 | DIAGNOSTICS PO2 ELECTRODE CLEANER Fisher Scientific Co., LLC | CHL |
| Mar 24, 1983 | K830578 | MICROHEMATOCRIT READER Fisher Scientific Co., LLC | JPI |
| Feb 18, 1983 | K830217 | REAGENTS CORNING CHLORIDE METER FOR Fisher Scientific Co., LLC | JFS |
| Feb 1, 1983 | K823930 | HEMATOLOGY QUALITY CONTROL MIXTURE Fisher Scientific Co., LLC | GJP |
| Jan 28, 1983 | K823929 | MULTIANALYTE CONTROLS-ALL KINDS Fisher Scientific Co., LLC | JJY |
| Jan 21, 1983 | K823558 | MICRO-HEMATOCRIT CENTRIFUGE 335/336 Fisher Scientific Co., LLC | JPI |
| Oct 18, 1982 | K822905 | LATEST RF KIT FOR RHEUMATOID FACTOR Fisher Scientific Co., LLC | DHR |
| Sep 21, 1982 | K822496 | SERA CHEM SMAC CALIBRATORS Fisher Scientific Co., LLC | JIT |
| Aug 16, 1982 | K822352 | HEMATOXYLIN STAIN SOLUTION Fisher Scientific Co., LLC | HYJ |
| Jun 24, 1982 | K821683 | REAGENT FOR COULTER COUNTER MODEL 5+11 Fisher Scientific Co., LLC | GIF |
| May 12, 1982 | K820731 | HEMATALL-C PLUS HEMATOLOGY CONTROLS Fisher Scientific Co., LLC | JPK |
| May 3, 1982 | K820996 | SALMONELLA & SHIGELLA GROUPING SERA Fisher Scientific Co., LLC | GRL |
| Dec 31, 1981 | K813505 | FLAME PHOTOMETER CALIBRATION STANDARDS Fisher Scientific Co., LLC | JIS |
| Nov 2, 1981 | K812623 | CLEANING SOLUTION FOR RADIOMETER OSM2 Fisher Scientific Co., LLC | CHL |
Newest 50 of 89.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2014 | Fisher Scientific Co Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack
Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic A Terminated |
KXG | None listed |
| Aug 12, 2013 | Fisher Scientific Co Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case.
Used in applying medications to or take specimens from a patient. Terminated |
KXG | None listed |