510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191021Substantially Equivalent

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye

Terragene LLC, Alvear, AR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K191021 is the FDA 510(k) clearance record for Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye, a class II device, cleared for Terragene S.A. on under FDA product code FRC (Indicator, Biological Sterilization Process). FDA records list 9 510(k) clearances for Terragene S.A., from to . As of , FDA records show one recall naming K191021.

Clearance record

Decision date
Received
(149 days to decision)
Product code
FRC Indicator, Biological Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Terragene S.A. Ruta Nacional # 9, Km 280, Parque Industrial Micropi, Alvear, AR
510(k) summary
Statement
Third party review
No

Clearances, product code FRC

Trailing 12 months
1 clearance under product code FRC in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260