510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161982Substantially Equivalent

C-Reactive Protein Kit for use on SPAPLUS

The Binding Site Group Ltd., Birmingham, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161982 is the FDA 510(k) clearance record for C-Reactive Protein Kit for use on SPAPLUS, a class II device, cleared for The Binding Site Group on under FDA product code DCN (System, Test, C-Reactive Protein). FDA records list 44 510(k) clearances for The Binding Site Group, from to . As of , FDA records show one recall naming K161982.

Clearance record

Decision date
Received
(260 days to decision)
Product code
DCN System, Test, C-Reactive Protein
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
The Binding Site Group 8 Calthorpe Rd., Birmingham, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DCN

Trailing 12 months

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

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