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510(k) K820996

SALMONELLA & SHIGELLA GROUPING SERA by Fisher Scientific Co., LLC — Product Code GRL

K820996 is an FDA 510(k) premarket notification submitted by Fisher Scientific Co., LLC for the device "SALMONELLA & SHIGELLA GROUPING SERA". The FDA issued a decision of Substantially Equivalent on May 3, 1982. The device falls under product code GRL (Antigens, All Groups, Salmonella Spp.), a Class II device regulated under 21 CFR 866.3550. Fisher Scientific Co., LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1982
Date Received
April 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Groups, Salmonella Spp.
Device Class
Class II
Regulation Number
866.3550
Review Panel
MI
Submission Type

Other clearances by Fisher Scientific Co., LLC

  • 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)

Other clearances for product code GRL

  • K945839 — SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA (March 7, 1995)

FDA data resources