The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Igm Immunotrubidimetric & Calibrator.
| Device ID | K955797 |
| 510k Number | K955797 |
| Device Name: | IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR |
| Classification | Igm, Antigen, Antiserum, Control |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | Julie Taylor |
| Correspondent | Julie Taylor RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Product Code | DFT |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-22 |
| Decision Date | 1996-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273204025 | K955797 | 000 |
| 05055273204001 | K955797 | 000 |