510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K882620Substantially Equivalent

Apolipoprotein for the Technicon Dpa-1(Tm) System

Technicon Instruments Corp., Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882620 is the FDA 510(k) clearance record for APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM, a class I device, cleared for Technicon Instruments Corp. on under FDA product code MSJ (Apolipoproteins). FDA records list 157 510(k) clearances for Technicon Instruments Corp., from to . As of , FDA records show no recalls naming K882620.

Clearance record

Decision date
Received
(14 days to decision)
Product code
MSJ Apolipoproteins
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Technicon Instruments Corp. 511 Benedict Ave., Tarrytown NY
Third party review
No

Clearances, product code MSJ

Trailing 12 months

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

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