510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070531Substantially Equivalent

Ise Module and Bar Code Reader Addition for the Datapro Clinical Chemistry Analyzer

Thermo Fisher Scientific Oy, Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070531 is the FDA 510(k) clearance record for ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER, a class II device, cleared for Thermo Fisher Scientific on under FDA product code CGZ (Electrode, Ion-Specific, Chloride). FDA records list 65 510(k) clearances for Thermo Fisher Scientific, from to . As of , FDA records show no recalls naming K070531.

Clearance record

Decision date
Received
(193 days to decision)
Product code
CGZ Electrode, Ion-Specific, Chloride
Regulation
21 CFR 862.1170
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Thermo Fisher Scientific 171 Industry Dr., Pittsburgh PA
510(k) summary
Summary PDF
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