510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971363Substantially Equivalent

Synchron Cx Systems Phosphorus Reagent

Carolina Liquid Chemistries, Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971363 is the FDA 510(k) clearance record for SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT, a class I device, cleared for Carolina Liquid Chemistries Corp. on under FDA product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus). FDA records list 21 510(k) clearances for Carolina Liquid Chemistries Corp., from to . As of , FDA records show no recalls naming K971363.

Clearance record

Decision date
Received
(14 days to decision)
Product code
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Regulation
21 CFR 862.1580
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Carolina Liquid Chemistries Corp. 451 W. Lambert Rd.,, Brea 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