Stratus CS Myo Calpak
FDA 510(k) K981101 · Dade Behring, Inc.
510(k) numberK981101
Submission
- Device name
- Stratus CS Myo Calpak
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- March 26, 1998
- Decision date
- April 15, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Stratus CS Myo Calpak cleared by the FDA?
Stratus CS Myo Calpak (K981101) received a 510(k) decision of Substantially Equivalent on April 15, 1998, 20 days after the submission was received.
What is the product code of K981101?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.