510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905829Substantially Equivalent

Determiner Pl/determination of Phospholipids

Kamiya Biomedical Company, LLC, Thousand Oaks CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905829 is the FDA 510(k) clearance record for DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS, a class I device, cleared for Kamiya Biomedical Co. on under FDA product code CEL (Ammonium Molybdate And Ammonium Vanadate, Phospholipids). FDA records list 46 510(k) clearances for Kamiya Biomedical Co., from to . As of , FDA records show no recalls naming K905829.

Clearance record

Decision date
Received
(30 days to decision)
Product code
CEL Ammonium Molybdate And Ammonium Vanadate, Phospholipids
Regulation
21 CFR 862.1575
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Kamiya Biomedical Co. P.O. Box 6067, Thousand Oaks CA
Third party review
No

Clearances, product code CEL

Trailing 12 months

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

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