510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013451Substantially Equivalent

Phoenoix Ise Reagents for Roche Hitachi, Models 700/900 Series

Phoenix Diagnostics, Inc., Natick MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013451 is the FDA 510(k) clearance record for PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES, a class II device, cleared for Phoenix Diagnostics, Inc. on under FDA product code CGZ (Electrode, Ion-Specific, Chloride). FDA records list 21 510(k) clearances for Phoenix Diagnostics, Inc., from to . As of , FDA records show no recalls naming K013451.

Clearance record

Decision date
Received
(61 days to decision)
Product code
CGZ Electrode, Ion-Specific, Chloride
Regulation
21 CFR 862.1170
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Phoenix Diagnostics, Inc. 8 Tech Cir., Natick MA
510(k) summary
Summary
Third party review
No

Clearances, product code CGZ

Trailing 12 months

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

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