510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813366Substantially Equivalent

Ammonia Test

Wako Pure Chemical Industries, Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813366 is the FDA 510(k) clearance record for AMMONIA TEST, a class I device, cleared for Wako Pure Chemical Industries, Ltd. on under FDA product code JID (Photometric Method, Ammonia). FDA records list 6 510(k) clearances for Wako Pure Chemical Industries, Ltd., from to . As of , FDA records show no recalls naming K813366.

Clearance record

Decision date
Received
(22 days to decision)
Product code
JID Photometric Method, Ammonia
Regulation
21 CFR 862.1065
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Wako Pure Chemical Industries, Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JID

Trailing 12 months
1 clearance under product code JID in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JID, 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 20261
October 20260