510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905144Substantially Equivalent

Eclipse Ica Glucose

Biotope, Inc., Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905144 is the FDA 510(k) clearance record for ECLIPSE ICA GLUCOSE, a class II device, cleared for Biotope, Inc. on under FDA product code CFR (Hexokinase, Glucose). FDA records list 7 510(k) clearances for Biotope, Inc., from to . As of , FDA records show no recalls naming K905144.

Clearance record

Decision date
Received
(50 days to decision)
Product code
CFR Hexokinase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Biotope, Inc. 12277 134th Ct., NE, Redmond WA
Third party review
No

Clearances, product code CFR

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