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510(k) K821184

SPIN CHEM REAGENTS & STANDARDS by Smithkline Diagnostics, Inc. — Product Code JIY

K821184 is an FDA 510(k) premarket notification submitted by Smithkline Diagnostics, Inc. for the device "SPIN CHEM REAGENTS & STANDARDS". The FDA issued a decision of Substantially Equivalent on May 24, 1982. The device falls under product code JIY (Photometric Method, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Smithkline Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1982
Date Received
April 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, Iron (Non-Heme)
Device Class
Class I
Regulation Number
862.1410
Review Panel
CH
Submission Type

Other clearances by Smithkline Diagnostics, Inc.

  • K961062 — FLEXSURE OBT (November 6, 1996)
  • K960183 — FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS F (June 7, 1996)
  • K934863 — FLEXSURE HP (May 18, 1994)
  • K880499 — HEMOCCULT SENSITIVE TEST (May 23, 1988)
  • K875131 — (SKD) CHOLESTEROL TEST KIT (March 1, 1988)
  • K862849 — HEMOCCULT WIPE TEST (December 9, 1986)
  • K854723 — SKD ELECTROCHEMICAL SYSTEM (ECS) (March 5, 1986)
  • K852841 — RAPID DIRECT STREP A LATEX AGGLUTINATION TEST (July 24, 1985)
  • K821884 — GASTROCCULT TM (October 8, 1982)
  • K821674 — SPINCHEM ACID PHOSPHATASE REAGENT (June 22, 1982)

Other clearances for product code JIY

  • K061793 — DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR (August 7, 2006)
  • K060264 — DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) (March 8, 2006)
  • K051115 — SENTINEL IRON LIQUID (August 25, 2005)
  • K033983 — VITALAB IRON REAGENT (May 21, 2004)
  • K030528 — ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) (June 17, 2003)
  • K020816 — IRON-PC-SL ASSAY MODEL # 151-10, 151-26 (May 14, 2002)
  • K013097 — WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 (November 13, 2001)
  • K981241 — IRON (May 1, 1998)
  • K973933 — SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 (November 4, 1997)
  • K972363 — IL TEST IRON (August 15, 1997)

FDA data resources