510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850603Substantially Equivalent

Spq Test System for Alpha(2) Macroglobulin

Applications Lab, Scarborough ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850603 is the FDA 510(k) clearance record for SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN, a class II device, cleared for Applications Lab on under FDA product code DEB (Alpha-2-Macroglobulin, Antigen, Antiserum, Control). FDA records list 10 510(k) clearances for Applications Lab, from to . As of , FDA records show no recalls naming K850603.

Clearance record

Decision date
Received
(18 days to decision)
Product code
DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5620
Device class
Class II
Review panel
Immunology
Applicant
Applications Lab 10 Nonesuch Rd., Scarborough ME
Third party review
No

Clearances, product code DEB

Trailing 12 months

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

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