EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS

Radioimmunoassay, Lsd (125-i)

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Emit Ii Lsd Assay, Emit Lsd Calibrators & Emit Lsd Controls.

Pre-market Notification Details

Device IDK955448
510k NumberK955448
Device Name:EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS
ClassificationRadioimmunoassay, Lsd (125-i)
Applicant BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose,  CA  95161 -9013
ContactPaul L Rogers, Jr.
CorrespondentPaul L Rogers, Jr.
BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose,  CA  95161 -9013
Product CodeDLB  
CFR Regulation Number862.3580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-29
Decision Date1996-02-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768020315 K955448 000
00842768002106 K955448 000
00842768002090 K955448 000
00842768002083 K955448 000
00842768002076 K955448 000
00842768002069 K955448 000
00842768002045 K955448 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.