The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Liquid Protein Calibrator.
Device ID | K061056 |
510k Number | K061056 |
Device Name: | RANDOX LIQUID PROTEIN CALIBRATOR |
Classification | Calibrator, Multi-analyte Mixture |
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 | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-17 |
Decision Date | 2006-07-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817439020321 | K061056 | 000 |
05055273204032 | K061056 | 000 |