510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K904188Substantially Equivalent

Ciba Corning Model 238 Ph/ Blood Gas Analyzer

Ciba Corning Diagnostics Corp., East Walpole MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904188 is the FDA 510(k) clearance record for CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER, a class II device, cleared for Ciba Corning Diagnostics Corp. on under FDA product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph). FDA records list 125 510(k) clearances for Ciba Corning Diagnostics Corp., from to . As of , FDA records show no recalls naming K904188.

Clearance record

Decision date
Received
(15 days to decision)
Product code
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Regulation
21 CFR 862.1120
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ciba Corning Diagnostics Corp. 333 Coney St., East Walpole MA
Third party review
No

Clearances, product code CHL

Trailing 12 months
1 clearance under product code CHL in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CHL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260