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510(k) K830032

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

K830032 is an FDA 510(k) premarket notification submitted by Sclavo, Inc. for the device "TOTAL IRON BINDING CAPACITY TEST". The FDA issued a decision of Substantially Equivalent on January 28, 1983. The device falls under product code JQF (Bathophenanthroline, Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Sclavo, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Sclavo, Inc.

  • K914789 — ELISA CMV IGM (March 4, 1992)
  • K914852 — ELISA TOXO IGM (January 23, 1992)
  • K914420 — ELISA RUBELLA IGM (December 27, 1991)
  • K895943 — NORMAL AND ABNORMAL CONTROL SERA (December 27, 1989)
  • K895822 — TOTAL BILIRUBIN L.F. (November 14, 1989)
  • K895847 — CREATININE 340 (ENZYMATIC) (October 30, 1989)
  • K880049 — CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE (January 27, 1989)
  • K873496 — ATYPICAL CHOLINESTERASE (January 27, 1989)
  • K880199 — CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE (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)

FDA data resources