510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861646Substantially Equivalent

Bio-Carb D16000, D16001, and D17000

Societe D' Analyses Bio-Pharmaceutiques,Inc., Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861646 is the FDA 510(k) clearance record for BIO-CARB D16000, D16001, AND D17000, a class II device, cleared for Societe D' Analyses Bio-Pharmaceutiques,Inc. on under FDA product code FJH (Dialyzer, Disposable). FDA records list one 510(k) clearance for Societe D' Analyses Bio-Pharmaceutiques,Inc. As of , FDA records show no recalls naming K861646.

Clearance record

Decision date
Received
(99 days to decision)
Product code
FJH Dialyzer, Disposable
Regulation
21 CFR 876.5830
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Societe D' Analyses Bio-Pharmaceutiques,Inc. P.O. Box 16598, Fort Worth TX
Third party review
No

Clearances, product code FJH

Trailing 12 months

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

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