510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K020972Substantially Equivalent

Wako RF-Ha (2), RF Calibrator, RF Calibrator Set

FUJIFILM Healthcare Americas Corporation, Richmond VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020972 is the FDA 510(k) clearance record for WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET, a class II device, cleared for Wako Chemicals USA, Inc. on under FDA product code DHR (System, Test, Rheumatoid Factor). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K020972.

Clearance record

Decision date
Received
(167 days to decision)
Product code
DHR System, Test, Rheumatoid Factor
Regulation
21 CFR 866.5775
Device class
Class II
Review panel
Immunology
Applicant
Wako Chemicals USA, Inc. 1600 Bellwood Rd., Richmond VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DHR

Trailing 12 months

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

FDA records show no clearances under product code DHR in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DHR, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260