510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K903052Substantially Equivalent

Immunocorp Lh Irma Coated Tube

Immunocorp Sciences, Inc., Montreal (Quebec), CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903052 is the FDA 510(k) clearance record for IMMUNOCORP LH IRMA COATED TUBE, a class I device, cleared for Immunocorp Sciences, Inc. on under FDA product code CEP (Radioimmunoassay, Luteinizing Hormone). FDA records list one 510(k) clearance for Immunocorp Sciences, Inc. As of , FDA records show no recalls naming K903052.

Clearance record

Decision date
Received
(49 days to decision)
Product code
CEP Radioimmunoassay, Luteinizing Hormone
Regulation
21 CFR 862.1485
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Immunocorp Sciences, Inc. 5800 Royalmount, Montreal (Quebec), CA
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