510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852532Substantially Equivalent

Newport Media Transfer Container

Newport Bio Systems, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852532 is the FDA 510(k) clearance record for NEWPORT MEDIA TRANSFER CONTAINER, a class I device, cleared for Newport Bio Systems on under FDA product code KJA (Flask, Tissue Culture). FDA records list one 510(k) clearance for Newport Bio Systems. As of , FDA records show no recalls naming K852532.

Clearance record

Decision date
Received
(69 days to decision)
Product code
KJA Flask, Tissue Culture
Regulation
21 CFR 864.2240
Device class
Class I
Review panel
Hematology
Applicant
Newport Bio Systems 1580 E. Edinger Ave., Suite C, Santa Ana CA
Third party review
No

Clearances, product code KJA

Trailing 12 months

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

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