510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K040750Substantially Equivalent

Bio-Chem Analyzer, Model 100

Clinical Analysis Corporation, Inc., Quakertown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K040750 is the FDA 510(k) clearance record for BIO-CHEM ANALYZER, MODEL 100, a class II device, cleared for Clinical Analysis Corporation, Inc. on under FDA product code CEM (Electrode, Ion Specific, Potassium). FDA records list one 510(k) clearance for Clinical Analysis Corporation, Inc. As of , FDA records show no recalls naming K040750.

Clearance record

Decision date
Received
(219 days to decision)
Product code
CEM Electrode, Ion Specific, Potassium
Regulation
21 CFR 862.1600
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Clinical Analysis Corporation, Inc. 2100 Quaker Pt.e Dr., Quakertown PA
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