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
K903854Substantially Equivalent

Rapitex(r) Asl New

Behring Diagnostics, Inc., Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903854 is the FDA 510(k) clearance record for RAPITEX(R) ASL NEW, a class I device, cleared for Behring Diagnostics, Inc. on under FDA product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent). FDA records list 145 510(k) clearances for Behring Diagnostics, Inc., from to . As of , FDA records show no recalls naming K903854.

Clearance record

Decision date
Received
(160 days to decision)
Product code
GTQ Antistreptolysin - Titer/Streptolysin O Reagent
Regulation
21 CFR 866.3720
Device class
Class I
Review panel
Microbiology
Applicant
Behring Diagnostics, Inc. 17 Chubb Way, Somerville NJ
Third party review
No

Clearances, product code GTQ

Trailing 12 months

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

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