510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K961889Substantially Equivalent

Specific Allergen Modules and Mixed Allergen Panels for Alastat Microplate and Alastat Eia Allergen-Specific Ige Systems

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

K961889 is the FDA 510(k) clearance record for SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS, a class II device, cleared for Diagnostic Products Corp. on under FDA product code DHB (System, Test, Radioallergosorbent (Rast) Immunological). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K961889.

Clearance record

Decision date
Received
(147 days to decision)
Product code
DHB System, Test, Radioallergosorbent (Rast) Immunological
Regulation
21 CFR 866.5750
Device class
Class II
Review panel
Immunology
Applicant
Diagnostic Products Corp. 5700 W. 96th St., Los Angeles CA
510(k) summary
Statement
Third party review
No

Clearances, product code DHB

Trailing 12 months
7 clearances under product code DHB in the twelve months to November 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DHB, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20260
May 20261
June 20261
July 20262
August 20260
September 20261
October 20260
November 20260