510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890561Substantially Equivalent

Spq(tm) Antibody Reagent Set II for Igm

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

K890561 is the FDA 510(k) clearance record for SPQ(TM) ANTIBODY REAGENT SET II FOR IGM, a class II device, cleared for Atlantic Antibodies on under FDA product code CFQ (Radioimmunoassay, Immunoglobulins (G, A, M)). FDA records list 18 510(k) clearances for Atlantic Antibodies, from to . As of , FDA records show no recalls naming K890561.

Clearance record

Decision date
Received
(30 days to decision)
Product code
CFQ Radioimmunoassay, Immunoglobulins (G, A, M)
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Atlantic Antibodies 10 Nonesuch Rd., Scarborough ME
Third party review
No

Clearances, product code CFQ

Trailing 12 months

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

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