The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Benzodiazepine Calibrator Set, Benzodiazepine Control Level 1, And Benzodiazepine Control Level 2.
| Device ID | K132090 |
| 510k Number | K132090 |
| Device Name: | BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 |
| Classification | Calibrators, Drug Specific |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-12 |
| Decision Date | 2013-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273207996 | K132090 | 000 |
| 05055273207989 | K132090 | 000 |
| 05055273207972 | K132090 | 000 |