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510(k) K830032

TOTAL IRON BINDING CAPACITY TEST by Sclavo, Inc. — Product Code JQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1983
Date Received
January 7, 1983
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

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  • K895943 — NORMAL AND ABNORMAL CONTROL SERA (December 27, 1989)
  • K895822 — TOTAL BILIRUBIN L.F. (November 14, 1989)
  • K895847 — CREATININE 340 (ENZYMATIC) (October 30, 1989)
  • K880199 — CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE (January 27, 1989)
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  • K873496 — ATYPICAL CHOLINESTERASE (January 27, 1989)
  • K884035 — SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER (December 29, 1988)

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)
  • K811942 — J & S IRON SATURATING REAGENT (September 8, 1981)
  • K810086 — IRON & TICB (January 28, 1981)
  • K792409 — ELVI TOTAL IRON BINDING CAPACITY (December 6, 1979)