Uriqual(Tm) Urinalysis Controls (Human) I & II
FDA 510(k) K881275 · Fisher Scientific Co., LLC
510(k) numberK881275
Submission
- Device name
- Uriqual(Tm) Urinalysis Controls (Human) I & II
- Applicant
- Fisher Scientific Co., LLC
Orangeburg, NY, US - Received
- March 25, 1988
- Decision date
- May 16, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K890534 | Modified Uriqual(Tm) Urinalysis Control Level 1JJW · Traditional | 03/08/1989SE |
| K874054 | Fisher Diagnostics Hematall III Las ReagentGGK · Traditional | 10/20/1987SE |
| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | 09/14/1987SE |
| K871058 | Serachem Liquid Spinal Fluid Control (Human)JJY · Traditional | 04/06/1987SE |
| K863224 | Hematall-C Plus Hematology ControlsJPK · Traditional | 10/29/1986SE |
| K862318 | Fisher Diagnostics Hematall-C CalibratorJPK · Traditional | 07/10/1986SE |
| K861185 | Therachem-Plus, Tri-Level TDC (TM)JJY · Traditional | 05/23/1986SE |
Questions and answers
When was Uriqual(Tm) Urinalysis Controls (Human) I & II cleared by the FDA?
Uriqual(Tm) Urinalysis Controls (Human) I & II (K881275) received a 510(k) decision of Substantially Equivalent on May 16, 1988, 52 days after the submission was received.
What is the product code of K881275?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.