510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915704Substantially Equivalent

Amylase (Kinetic) Reagent Set

Tech Intl. Co., Placentia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915704 is the FDA 510(k) clearance record for AMYLASE (KINETIC) REAGENT SET, a class II device, cleared for Tech Intl. Co. on under FDA product code CJD (Nitrosalicylate Reduction, Amylase). FDA records list 13 510(k) clearances for Tech Intl. Co., from to . As of , FDA records show no recalls naming K915704.

Clearance record

Decision date
Received
(1,675 days to decision)
Product code
CJD Nitrosalicylate Reduction, Amylase
Regulation
21 CFR 862.1070
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Tech Intl. Co. 911 Via Rodeo, Placentia CA
510(k) summary
Statement
Third party review
No

Clearances, product code CJD

Trailing 12 months

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

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