510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K981912Substantially Equivalent

Human Iga Subclass Bnii Combi Kit

The Binding Site, Santa Monica CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981912 is the FDA 510(k) clearance record for HUMAN IGA SUBCLASS BNII COMBI KIT, a class II device, cleared for The Binding Site, Ltd. on under FDA product code CFN (Method, Nephelometric, Immunoglobulins (G, A, M)). FDA records list 125 510(k) clearances for The Binding Site, Ltd., from to . As of , FDA records show no recalls naming K981912.

Clearance record

Decision date
Received
(186 days to decision)
Product code
CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
The Binding Site, Ltd. East Tower, Suite 600, Santa Monica CA
510(k) summary
Statement
Third party review
No

Clearances, product code CFN

Trailing 12 months

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

FDA records show no clearances under product code CFN in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CFN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260