510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120615Substantially Equivalent

Alere Cholestech Ldx Analyzer, Alere Cholestech Ldx Lipid Profile - Glu Cassette

Alere San Diego Inc. dba Biosite,Innovacon,Hemosen, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120615 is the FDA 510(k) clearance record for ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE, a class II device, cleared for Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen on under FDA product code CGA (Glucose Oxidase, Glucose). FDA records list one 510(k) clearance for Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen. As of , FDA records show 5 recalls naming K120615.

Clearance record

Decision date
Received
(441 days to decision)
Product code
CGA Glucose Oxidase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen 9975 Summers Ridge Rd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CGA

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