510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K880353Substantially Equivalent

Ciba Corning Model 280 Ph/blood Gas System

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

K880353 is the FDA 510(k) clearance record for CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM, a class II device, cleared for Ciba Corning Diagnostics Corp. on under FDA product code GKR (System, Hemoglobin, Automated). FDA records list 125 510(k) clearances for Ciba Corning Diagnostics Corp., from to . As of , FDA records show no recalls naming K880353.

Clearance record

Decision date
Received
(141 days to decision)
Product code
GKR System, Hemoglobin, Automated
Regulation
21 CFR 864.5620
Device class
Class II
Review panel
Hematology
Applicant
Ciba Corning Diagnostics Corp. 333 Coney St., East Walpole MA
Third party review
No

Clearances, product code GKR

Trailing 12 months

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

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