The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Uriqual(tm) Urinalysis Controls (human) I & Ii.
| Device ID | K881275 |
| 510k Number | K881275 |
| Device Name: | URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg, NY 10962 |
| Contact | B Breuer,phd |
| Correspondent | B Breuer,phd FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg, NY 10962 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-25 |
| Decision Date | 1988-05-16 |