510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962041Substantially Equivalent

Acs Lh2 Immunoassay

Ciba Corning Diagnostics Corp., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962041 is the FDA 510(k) clearance record for ACS LH2 IMMUNOASSAY, a class I device, cleared for Ciba Corning Diagnostics Corp. on under FDA product code CEP (Radioimmunoassay, Luteinizing Hormone). FDA records list 125 510(k) clearances for Ciba Corning Diagnostics Corp., from to . As of , FDA records show no recalls naming K962041.

Clearance record

Decision date
Received
(24 days to decision)
Product code
CEP Radioimmunoassay, Luteinizing Hormone
Regulation
21 CFR 862.1485
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Ciba Corning Diagnostics Corp. 17392 Daimler St., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code CEP

Trailing 12 months

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

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