510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901859Substantially Equivalent

Coat-a-Count Total Ige Irma, Catalog #Ikie1, Ikie2

Siemens Healthcare Diagnostics Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901859 is the FDA 510(k) clearance record for COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2, a class II device, cleared for Diagnostic Products Corp. on under FDA product code JHR (Radioimmunoassay, Immunoglobulins (D, E)). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K901859.

Clearance record

Decision date
Received
(9 days to decision)
Product code
JHR Radioimmunoassay, Immunoglobulins (D, E)
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Diagnostic Products Corp. 5700 W. 96th St., Los Angeles CA
Third party review
No

Clearances, product code JHR

Trailing 12 months

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

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