510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K961359Substantially Equivalent

Liquitrol-Tm, Tumor Marker Control, Level 1 and 2

Bioprocessing, Inc., Scarborough ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961359 is the FDA 510(k) clearance record for LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2, a class I device, cleared for Bioprocessing, Inc. on under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)). FDA records list one 510(k) clearance for Bioprocessing, Inc. As of , FDA records show no recalls naming K961359.

Clearance record

Decision date
Received
(157 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
Bioprocessing, Inc. 18 Mussey Rd., Scarborough ME
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJY, 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