510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K880546Substantially Equivalent

Total Iron Binding Capacity (Tibc)

Boehringer Mannheim Corp., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880546 is the FDA 510(k) clearance record for TOTAL IRON BINDING CAPACITY (TIBC), a class I device, cleared for Boehringer Mannheim Corp. on under FDA product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K880546.

Clearance record

Decision date
Received
(44 days to decision)
Product code
JMO Ferrozine (Colorimetric) Iron Binding Capacity
Regulation
21 CFR 862.1415
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Boehringer Mannheim Corp. 9115 Hague Rd., Indianapolis IN
Third party review
No

Clearances, product code JMO

Trailing 12 months

FDA records hold no clearances under product code JMO in the trailing twelve months.

FDA records show no clearances under product code JMO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JMO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260