510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K892238Substantially Equivalent

Cla 200 Chempro(r) Lipid Analyzer

Johnson & Johnson Professionals, Inc., Roseville MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892238 is the FDA 510(k) clearance record for CLA 200 CHEMPRO(R) LIPID ANALYZER, a class I device, cleared for Johnson & Johnson Professionals, Inc. on under FDA product code CHH (Enzymatic Esterase--Oxidase, Cholesterol). FDA records list 206 510(k) clearances for Johnson & Johnson Professionals, Inc., from to . As of , FDA records show no recalls naming K892238.

Clearance record

Decision date
Received
(64 days to decision)
Product code
CHH Enzymatic Esterase--Oxidase, Cholesterol
Regulation
21 CFR 862.1175
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Johnson & Johnson Professionals, Inc. 2675 Long Lake Rd., Roseville MN
Third party review
No

Clearances, product code CHH

Trailing 12 months
1 clearance under product code CHH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CHH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260