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510(k) K792409

ELVI TOTAL IRON BINDING CAPACITY by Volu Sol Medical Industries — Product Code JQF

K792409 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "ELVI TOTAL IRON BINDING CAPACITY". The FDA issued a decision of Substantially Equivalent on December 6, 1979. The device falls under product code JQF (Bathophenanthroline, Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Volu Sol Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1979
Date Received
November 26, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bathophenanthroline, Iron Binding Capacity
Device Class
Class I
Regulation Number
862.1415
Review Panel
CH
Submission Type

Other clearances by Volu Sol Medical Industries

  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)
  • K822126 — VOLU-SOL CARNOY FLUID (August 5, 1982)
  • K822128 — VOLU-SOL SINGLE DIFFERENTIAL STAIN (August 5, 1982)
  • K822035 — VOLU-SOL GILLS EA (August 3, 1982)
  • K822037 — VOLU-SOL TAP WATER SUBSTITUTE (August 3, 1982)
  • K822038 — VOLU-SOL ORANGE G-6(GILLS-MOD (August 3, 1982)
  • K822036 — VOLU-SOL DECALCIFER (August 3, 1982)
  • K812906 — ELVI BICLOT 816 (July 22, 1982)
  • K821540 — HEMATOXYLIN II (June 10, 1982)

Other clearances for product code JQF

  • K051111 — SENTINEL UIBC LIQUID (November 17, 2005)
  • K984122 — WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR (January 20, 1999)
  • K875176 — WAKO(TM) UIBC (February 2, 1988)
  • K863066 — TRANSFERMETER (December 4, 1986)
  • K830032 — TOTAL IRON BINDING CAPACITY TEST (January 28, 1983)
  • K811942 — J & S IRON SATURATING REAGENT (September 8, 1981)
  • K810086 — IRON & TICB (January 28, 1981)

FDA data resources