510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K920216Substantially Equivalent

Syn Elisa Micro Albumin

Elias U.S.A., Inc., Osceola WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920216 is the FDA 510(k) clearance record for SYN ELISA MICRO ALBUMIN, a class I device, cleared for Elias U.S.A., Inc. on under FDA product code JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)). FDA records list 54 510(k) clearances for Elias U.S.A., Inc., from to . As of , FDA records show no recalls naming K920216.

Clearance record

Decision date
Received
(55 days to decision)
Product code
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Regulation
21 CFR 862.1645
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Elias U.S.A., Inc. 373 280th St., Osceola WI
510(k) summary
Statement
Third party review
No

Clearances, product code JIR

Trailing 12 months

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

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