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510(k) K912912

SYNERMED SERUM IRON-600 REAGENT KIT by Synermed, Inc. — Product Code CFM

K912912 is an FDA 510(k) premarket notification submitted by Synermed, Inc. for the device "SYNERMED SERUM IRON-600 REAGENT KIT". The FDA issued a decision of Substantially Equivalent on July 30, 1991. The device falls under product code CFM (Bathophenanthroline, Colorimetry, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Synermed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1991
Date Received
July 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Synermed, Inc.

  • K973109 — SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT (September 25, 1997)
  • K972716 — SYNERMED TOTAL BILIRUBIN REAGENT KIT (August 7, 1997)
  • K971491 — SYNERMED IR 200 CHEMISTRY ANALYZER (June 26, 1997)
  • K962479 — SYNERMED ISE REAGENTS (March 3, 1997)
  • K963939 — SYNERMED DIRECT BILIRUBIN REAGENT KIT (December 18, 1996)
  • K960793 — SYNERMED ENZYMATIC CO2 REAGENT KIT (March 11, 1996)
  • K953395 — SYNERMED CALCIUM REAGENT KIT (August 31, 1995)
  • K952179 — SYNERMED ISE REAGENTS (June 20, 1995)
  • K943924 — CREATININE-PO REAGENT KIT (September 20, 1994)
  • K941091 — SYNERMED AMYLASE REAGENT KIT (May 3, 1994)

Other clearances for product code CFM

  • K984119 — WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR (January 15, 1999)
  • K981581 — IRON (June 8, 1998)
  • K932871 — UIBC FOR DISCREET RANDOM ACCESS ANALYZER (September 8, 1993)
  • K913705 — ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 (October 9, 1991)
  • K902918 — SYNERMED SERUM IRON REAGENT KIT (July 31, 1990)
  • K895047 — CLINISTAT POTASSIUM REAGENT TEST (October 17, 1989)
  • K891155 — IRON REAGENT (April 18, 1989)
  • K873120 — ABBOTT A-GENT IRON REAGENT KIT (August 25, 1987)
  • K861602 — TOTAL IRON BINDING CAPACITY PROCEDURE (May 23, 1986)
  • K854305 — DART IRON & IRON BINDING CAPACITY REAGENT (November 12, 1985)

FDA data resources