510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K981734Substantially Equivalent

Vtec-Rpla Seiken

Denka Seiken'S, Tokyo, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981734 is the FDA 510(k) clearance record for VTEC-RPLA SEIKEN, a class I device, cleared for Denka Seiken'S on under FDA product code GNA (Antisera, All Types, Escherichia Coli). FDA records list 4 510(k) clearances for Denka Seiken'S, from to . As of , FDA records show no recalls naming K981734.

Clearance record

Decision date
Received
(127 days to decision)
Product code
GNA Antisera, All Types, Escherichia Coli
Regulation
21 CFR 866.3255
Device class
Class I
Review panel
Microbiology
Applicant
Denka Seiken'S 3-4-2 Nihonbashi, Tokyo, JP
510(k) summary
Summary
Third party review
No

Clearances, product code GNA

Trailing 12 months

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

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