Fisher Scientific Co., LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 89
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0163-2023 | Class II | Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 50 | January 17, 2023 |
| D-0164-2023 | Class II | Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo | January 17, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K930415 | MICROHEMATOCRIT ROTOR | March 23, 1993 |
| K915825 | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE | March 11, 1992 |
| K915441 | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE | January 8, 1992 |
| K890534 | MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 | March 8, 1989 |
| K881275 | URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II | May 16, 1988 |
| K874054 | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT | October 20, 1987 |
| K872916 | HISTOMATIC SLIDE STAINER, CODE-ON VERSION | September 14, 1987 |
| K871058 | SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) | April 6, 1987 |
| K863224 | HEMATALL-C PLUS HEMATOLOGY CONTROLS | October 29, 1986 |
| K862318 | FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR | July 10, 1986 |
| K861185 | THERACHEM-PLUS, TRI-LEVEL TDC (TM) | May 23, 1986 |
| K860919 | THERACHEM, TDC THERAPEUTIC DRUG CONTROLS | April 11, 1986 |
| K853241 | HEMATOLOGY STAIN PACK | August 19, 1985 |
| K851151 | FISHER DIAGNOSTICS KDA CALIBRATOR II | May 20, 1985 |
| K851150 | FISHER DIAGNOSTICS KDA CALIBRATOR I | May 20, 1985 |
| K850636 | SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E | March 20, 1985 |
| K844168 | AMYLASE REAGENT CS-726 | November 20, 1984 |
| K843452 | STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ | September 27, 1984 |
| K840111 | TOTAL BILIRUBIN | March 19, 1984 |
| K833950 | TOTAL PROTEIN REAGENT CS-724 | January 13, 1984 |