Document(Tm) Uric Acid Linearity Test Set
FDA 510(k) K893139 · Casco Standards
510(k) numberK893139
Submission
- Device name
- Document(Tm) Uric Acid Linearity Test Set
- Applicant
- Casco Standards
Yarmouth, ME, US - Received
- April 25, 1989
- Decision date
- July 20, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Document(Tm) Uric Acid Linearity Test Set cleared by the FDA?
Document(Tm) Uric Acid Linearity Test Set (K893139) received a 510(k) decision of Substantially Equivalent on July 20, 1989, 86 days after the submission was received.
What is the product code of K893139?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.