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510(k) K811942

J & S IRON SATURATING REAGENT by Thyroid Diagnostics, Inc. — Product Code JQF

K811942 is an FDA 510(k) premarket notification submitted by Thyroid Diagnostics, Inc. for the device "J & S IRON SATURATING REAGENT". The FDA issued a decision of Substantially Equivalent on September 8, 1981. The device falls under product code JQF (Bathophenanthroline, Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Thyroid Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1981
Date Received
July 7, 1981
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 Thyroid Diagnostics, Inc.

  • K852111 — GLYCO-CHECK (July 5, 1985)

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)
  • K810086 — IRON & TICB (January 28, 1981)
  • K792409 — ELVI TOTAL IRON BINDING CAPACITY (December 6, 1979)

FDA data resources