510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871284Substantially Equivalent

Flow Pac Total Iron Reagents:2183,2349,2312,014339

American Research Products Co., Solon OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871284 is the FDA 510(k) clearance record for FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339, a class I device, cleared for American Research Products Co. on under FDA product code JIY (Photometric Method, Iron (Non-Heme)). FDA records list 56 510(k) clearances for American Research Products Co., from to . As of , FDA records show no recalls naming K871284.

Clearance record

Decision date
Received
(8 days to decision)
Product code
JIY Photometric Method, Iron (Non-Heme)
Regulation
21 CFR 862.1410
Device class
Class I
Review panel
Clinical Chemistry
Applicant
American Research Products Co. 30175 Solon Industrial Pkwy., Solon OH
Third party review
No

Clearances, product code JIY

Trailing 12 months

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

FDA records show no clearances under product code JIY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JIY, 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