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510(k) K810086

IRON & TICB by Bio-Analytics Laboratories, Inc. — Product Code JQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1981
Date Received
January 13, 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 Bio-Analytics Laboratories, Inc.

  • K861638 — KINETIC ALKALINE PHOSPHATASE REAGENT KIT (May 29, 1986)
  • K860245 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 14, 1986)
  • K860213 — ALBUMIN REAGENT KIT (February 11, 1986)
  • K851513 — ULTRA-VIOLET BUN REAGENT KIT (May 20, 1985)
  • K851514 — ULTRA-VIOLET GLUCOSE REAGENT (May 20, 1985)
  • K850639 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 5, 1985)
  • K832771 — ERYTHROCYTE TEST (October 28, 1983)
  • K832567 — ACETAMINOPHEN(PARACETAMOL (September 12, 1983)
  • K831414 — COLORIMETRIC BUN (June 16, 1983)
  • K821934 — BIO-CAL OPERATION CHECK KIT (July 20, 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)
  • K792409 — ELVI TOTAL IRON BINDING CAPACITY (December 6, 1979)