Accufibrin(Tm) Blood Collection System AF100
FDA 510(k) K882501 · Terumo Medical Corp.
510(k) numberK882501
Submission
- Device name
- Accufibrin(Tm) Blood Collection System AF100
- Applicant
- Terumo Medical Corp.
Elkton, MD, US - Received
- June 17, 1988
- Decision date
- July 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Accufibrin(Tm) Blood Collection System AF100 cleared by the FDA?
Accufibrin(Tm) Blood Collection System AF100 (K882501) received a 510(k) decision of Substantially Equivalent on July 18, 1988, 31 days after the submission was received.
What is the product code of K882501?
The FDA product code is GIM – Tubes, Vacuum Sample, With Anticoagulant, a Class II (moderate risk) device regulated under 21 CFR 862.1675.