510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974858Substantially Equivalent

Phosphorus-Sl Assay, Catalogue Number 117-10, 117-30

Sekisui Diagnostics P.E.I. Inc., Charlottetown, P.E.I., CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974858 is the FDA 510(k) clearance record for PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30, a class I device, cleared for Diagnostic Chemicals , Ltd. on under FDA product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus). FDA records list 72 510(k) clearances for Sekisui Diagnostics P.E.I. Inc., from to . As of , FDA records show no recalls naming K974858.

Clearance record

Decision date
Received
(32 days to decision)
Product code
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Regulation
21 CFR 862.1580
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Diagnostic Chemicals , Ltd. West Royalty Industrial Park,, Charlottetown, P.E.I., CA
510(k) summary
Statement
Third party review
No

Clearances, product code CEO

Trailing 12 months

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

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