The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Therapeutic Drug Calibrator.
Device ID | K012318 |
510k Number | K012318 |
Device Name: | RANDOX THERAPEUTIC DRUG CALIBRATOR |
Classification | Calibrators, Drug Mixture |
Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
Contact | P Armstrong |
Correspondent | P Armstrong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
Product Code | DKB |
CFR Regulation Number | 862.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-23 |
Decision Date | 2001-09-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414597607 | K012318 | 000 |
00630414470351 | K012318 | 000 |
05055273206470 | K012318 | 000 |