The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Modified Uriqual(tm) Urinalysis Control Level 1.
| Device ID | K890534 |
| 510k Number | K890534 |
| Device Name: | MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| 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 | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-26 |
| Decision Date | 1989-03-08 |