Direct Biliruben Calibrations
FDA 510(k) K852067 · Data Medical Associates, Inc.
510(k) numberK852067
Submission
- Device name
- Direct Biliruben Calibrations
- Applicant
- Data Medical Associates, Inc.
Arlington, TX, US - Received
- May 10, 1985
- Decision date
- May 31, 1985
- 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 Direct Biliruben Calibrations cleared by the FDA?
Direct Biliruben Calibrations (K852067) received a 510(k) decision of Substantially Equivalent on May 31, 1985, 21 days after the submission was received.
What is the product code of K852067?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.