510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K131727Substantially Equivalent

Cera-Chek 1070 Blood Glucose Monitoring System

Ceragem Medisys, Inc., Cheonan Si, Chungcheongnam-Do, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131727 is the FDA 510(k) clearance record for CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM, a class II device, cleared for Ceragem Medisys, Inc. on under FDA product code LFR (Glucose Dehydrogenase, Glucose). FDA records list 4 510(k) clearances for Ceragem Medisys, Inc., from to . As of , FDA records show no recalls naming K131727.

Clearance record

Decision date
Received
(261 days to decision)
Product code
LFR Glucose Dehydrogenase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ceragem Medisys, Inc.
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFR

Trailing 12 months

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

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