510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K981915Substantially Equivalent

Turbidimetric/nephelometric Human Complememt Reference Preparation

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

K981915 is the FDA 510(k) clearance record for TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION, a class I device, cleared for The Binding Site, Ltd. on under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)). FDA records list 125 510(k) clearances for The Binding Site, Ltd., from to . As of , FDA records show no recalls naming K981915.

Clearance record

Decision date
Received
(567 days to decision)
Product code
JJY Multi-Analyte Controls, All Kinds (Assayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
The Binding Site, Ltd. East Tower, Suite 600, Santa Monica CA
510(k) summary
Statement
Third party review
No

Clearances, product code JJY

Trailing 12 months

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

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