510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K790485Substantially Equivalent

Amylochrome Stat Separator, Test

Hoffmann-La Roche, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790485 is the FDA 510(k) clearance record for AMYLOCHROME STAT SEPARATOR, TEST, a class II device, cleared for Hoffmann-La Roche, Inc. on under FDA product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection). FDA records list 49 510(k) clearances for Hoffmann-La Roche, Inc., from to . As of , FDA records show no recalls naming K790485.

Clearance record

Decision date
Received
(52 days to decision)
Product code
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Hoffmann-La Roche, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JKA

Trailing 12 months
6 clearances under product code JKA in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code JKA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20263
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260