510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113349Substantially Equivalent

Human Ch50 Reagent Pack for Use on the Spaplus, Human Ch50 Calibrator Set for Use on the Spaplus, Human Ch50 Controls Fo

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

K113349 is the FDA 510(k) clearance record for HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO, a class II device, cleared for The Binding Site Group , Ltd. on under FDA product code DAE (Complement C9, Antigen, Antiserum, Control). FDA records list 44 510(k) clearances for The Binding Site Group , Ltd., from to . As of , FDA records show no recalls naming K113349.

Clearance record

Decision date
Received
(240 days to decision)
Product code
DAE Complement C9, Antigen, Antiserum, Control
Regulation
21 CFR 866.5240
Device class
Class II
Review panel
Immunology
Applicant
The Binding Site Group , Ltd. 8 Calthorpe Rd., Birmingham, GB
510(k) summary
Statement
Third party review
No

Clearances, product code DAE

Trailing 12 months

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

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