510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K991787Substantially Equivalent

N Latex Ige Mono Reagent

Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991787 is the FDA 510(k) clearance record for N LATEX IGE MONO REAGENT, a class II device, cleared for Dade Behring, Inc. on under FDA product code DGC (Ige, Antigen, Antiserum, Control). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K991787.

Clearance record

Decision date
Received
(43 days to decision)
Product code
DGC Ige, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Dade Behring, Inc. Glasgow Business Community;, P.O. Box 6101, Newark DE
510(k) summary
Summary
Third party review
No

Clearances, product code DGC

Trailing 12 months

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

FDA records show no clearances under product code DGC in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DGC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260