Directdraw Superserum
FDA 510(k) K921778 · International Technidyne Corp.
510(k) numberK921778
Submission
- Device name
- Directdraw Superserum
- Applicant
- International Technidyne Corp.
Edison, NJ, US - Received
- April 14, 1992
- Decision date
- May 28, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GIM – Tubes, Vacuum Sample, With Anticoagulant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
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Questions and answers
When was Directdraw Superserum cleared by the FDA?
Directdraw Superserum (K921778) received a 510(k) decision of Substantially Equivalent on May 28, 1992, 44 days after the submission was received.
What is the product code of K921778?
The FDA product code is GIM – Tubes, Vacuum Sample, With Anticoagulant, a Class II (moderate risk) device regulated under 21 CFR 862.1675.