510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870865Substantially Equivalent

Tissue Culture Bag

American Fluoroseal Corp., Silver Spring MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870865 is the FDA 510(k) clearance record for TISSUE CULTURE BAG, a class I device, cleared for American Fluoroseal Corp. on under FDA product code KJA (Flask, Tissue Culture). FDA records list 2 510(k) clearances for American Fluoroseal Corp., from to . As of , FDA records show no recalls naming K870865.

Clearance record

Decision date
Received
(27 days to decision)
Product code
KJA Flask, Tissue Culture
Regulation
21 CFR 864.2240
Device class
Class I
Review panel
Hematology
Applicant
American Fluoroseal Corp. 204 Stonegate Dr., Silver Spring MD
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