Unimeter Calibration Kit
FDA 510(k) K880610 · Boehringer Mannheim Corp.
510(k) numberK880610
Submission
- Device name
- Unimeter Calibration Kit
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- February 12, 1988
- Decision date
- March 24, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIW – Calibrator, Surrogate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Unimeter Calibration Kit cleared by the FDA?
Unimeter Calibration Kit (K880610) received a 510(k) decision of Substantially Equivalent on March 24, 1988, 41 days after the submission was received.
What is the product code of K880610?
The FDA product code is JIW – Calibrator, Surrogate, a Class II (moderate risk) device regulated under 21 CFR 862.1150.