510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980525Substantially Equivalent

Ubas Manual Method and Ubas Automated Method

Marukin Shoyu Co., Ltd., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980525 is the FDA 510(k) clearance record for UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD, a class II device, cleared for Marukin Shoyu Co., Ltd. on under FDA product code KWX (Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids). FDA records list one 510(k) clearance for Marukin Shoyu Co., Ltd. As of , FDA records show no recalls naming K980525.

Clearance record

Decision date
Received
(63 days to decision)
Product code
KWX Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids
Regulation
21 CFR 862.1187
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Marukin Shoyu Co., Ltd. 3722 Ave. Sausalito, Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code KWX

Trailing 12 months

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

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