DRI-LYTE
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
MALLINCKRODT CRITICAL CARE
The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Dri-lyte.
Pre-market Notification Details
| Device ID | K780353 |
| 510k Number | K780353 |
| Device Name: | DRI-LYTE |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-03 |
| Decision Date | 1978-04-05 |
Trademark Results [DRI-LYTE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DRI-LYTE 73132417 1083148 Dead/Cancelled |
Mallinckrodt, Inc. 1977-06-30 |
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