510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853441Substantially Equivalent

Fetal Bovine Serum in Transfer Container

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

K853441 is the FDA 510(k) clearance record for FETAL BOVINE SERUM IN TRANSFER CONTAINER, a class I device, cleared for Newport Biosystems, Inc. on under FDA product code KJA (Flask, Tissue Culture). FDA records list 4 510(k) clearances for Newport Biosystems, Inc., from to . As of , FDA records show no recalls naming K853441.

Clearance record

Decision date
Received
(13 days to decision)
Product code
KJA Flask, Tissue Culture
Regulation
21 CFR 864.2240
Device class
Class I
Review panel
Hematology
Applicant
Newport Biosystems, Inc. Rod Roberts, 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