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 |