510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961807Substantially Equivalent

Certain Hct Level a & Level B/cvm Hct Levels 1,2,3, & 4

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

K961807 is the FDA 510(k) clearance record for CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4, a class II device, cleared for Ciba Corning Diagnostics Corp. on under FDA product code GLK (Control, Hematocrit). FDA records list 125 510(k) clearances for Ciba Corning Diagnostics Corp., from to . As of , FDA records show no recalls naming K961807.

Clearance record

Decision date
Received
(77 days to decision)
Product code
GLK Control, Hematocrit
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Ciba Corning Diagnostics Corp. 63 N. St., Medfield MA
510(k) summary
Summary
Third party review
No

Clearances, product code GLK

Trailing 12 months

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

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