510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K896902Substantially Equivalent

Enzymun Test R Ige

Boehringer Mannheim Corp., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896902 is the FDA 510(k) clearance record for ENZYMUN TEST R IGE, a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code DHB (System, Test, Radioallergosorbent (Rast) Immunological). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K896902.

Clearance record

Decision date
Received
(33 days to decision)
Product code
DHB System, Test, Radioallergosorbent (Rast) Immunological
Regulation
21 CFR 866.5750
Device class
Class II
Review panel
Immunology
Applicant
Boehringer Mannheim Corp. 9115 Hague Rd., Indianapolis IN
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