510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802420Substantially Equivalent

Centrifichem Inorganic Phosphorus

Union Carbide Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802420 is the FDA 510(k) clearance record for CENTRIFICHEM INORGANIC PHOSPHORUS, a class I device, cleared for Union Carbide Corp. on under FDA product code CED (5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase). FDA records list 69 510(k) clearances for Union Carbide Corp., from to . As of , FDA records show no recalls naming K802420.

Clearance record

Decision date
Received
(25 days to decision)
Product code
CED 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
Regulation
21 CFR 862.1520
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Union Carbide Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CED

Trailing 12 months

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

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