510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070064Substantially Equivalent

Amylase Eps Reagent

Thermo Fisher Scientific Oy, Noble Park, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K070064 is the FDA 510(k) clearance record for AMYLASE EPS REAGENT, a class II device, cleared for Thermo Fisher Scientific on under FDA product code JFJ (Catalytic Methods, Amylase). FDA records list 65 510(k) clearances for Thermo Fisher Scientific, from to . As of , FDA records show no recalls naming K070064.

Clearance record

Decision date
Received
(137 days to decision)
Product code
JFJ Catalytic Methods, Amylase
Regulation
21 CFR 862.1070
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Thermo Fisher Scientific 189-199 Browns Rd., Noble Park, AU
510(k) summary
Statement
Third party review
No

Clearances, product code JFJ

Trailing 12 months

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

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