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.
Device ID | K955448 |
510k Number | K955448 |
Device Name: | EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS |
Classification | Radioimmunoassay, Lsd (125-i) |
Applicant | BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
Contact | Paul L Rogers, Jr. |
Correspondent | Paul L Rogers, Jr. BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
Product Code | DLB |
CFR Regulation Number | 862.3580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-29 |
Decision Date | 1996-02-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768020315 | K955448 | 000 |
00842768002106 | K955448 | 000 |
00842768002090 | K955448 | 000 |
00842768002083 | K955448 | 000 |
00842768002076 | K955448 | 000 |
00842768002069 | K955448 | 000 |
00842768002045 | K955448 | 000 |