510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955448Substantially Equivalent

Emit II Lsd Assay, Emit Lsd Calibrators & Emit Lsd Controls

Behring Diagnostics, Inc., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955448 is the FDA 510(k) clearance record for EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS, a class II device, cleared for Behring Diagnostics, Inc. on under FDA product code DLB (Radioimmunoassay, Lsd (125-I)). FDA records list 145 510(k) clearances for Behring Diagnostics, Inc., from to . As of , FDA records show no recalls naming K955448.

Clearance record

Decision date
Received
(86 days to decision)
Product code
DLB Radioimmunoassay, Lsd (125-I)
Regulation
21 CFR 862.3580
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Behring Diagnostics, Inc. 3403 Yerba Buena Rd., San Jose CA
510(k) summary
Summary
Third party review
No

Clearances, product code DLB

Trailing 12 months

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

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