510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961115Substantially Equivalent

Ektachem Clinical Chemistry Slide Potassium (K+)

Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961115 is the FDA 510(k) clearance record for EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+), a class II device, cleared for Johnson & Johnson Clinical Diagnostics, Inc. on under FDA product code CEM (Electrode, Ion Specific, Potassium). FDA records list 33 510(k) clearances for Johnson & Johnson Clinical Diagnostics, Inc., from to . As of , FDA records show no recalls naming K961115.

Clearance record

Decision date
Received
(48 days to decision)
Product code
CEM Electrode, Ion Specific, Potassium
Regulation
21 CFR 862.1600
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Johnson & Johnson Clinical Diagnostics, Inc. 100 Indigo Creek Dr., Rochester NY
510(k) summary
Statement
Third party review
No

Clearances, product code CEM

Trailing 12 months
1 clearance under product code CEM 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 CEM, 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