Monoject Blood Collection Tubes W/Safety Stopper
FDA 510(k) K940058 · Sherwood Medical Co.
510(k) numberK940058
Submission
- Device name
- Monoject Blood Collection Tubes W/Safety Stopper
- Applicant
- Sherwood Medical Co.
St. Louis, MO, US - Received
- January 5, 1994
- Decision date
- May 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Monoject Blood Collection Tubes W/Safety Stopper cleared by the FDA?
Monoject Blood Collection Tubes W/Safety Stopper (K940058) received a 510(k) decision of Substantially Equivalent on May 2, 1994, 117 days after the submission was received.
What is the product code of K940058?
The FDA product code is GIM – Tubes, Vacuum Sample, With Anticoagulant, a Class II (moderate risk) device regulated under 21 CFR 862.1675.