Coagulation Reference Plasma, Abnormal
FDA 510(k) K904073 · Medi-Tech, Inc.
510(k) numberK904073
Submission
- Device name
- Coagulation Reference Plasma, Abnormal
- Applicant
- Medi-Tech, Inc.
Ventura, CA, US - Received
- September 5, 1990
- Decision date
- October 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGC – Control, Plasma, Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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Questions and answers
When was Coagulation Reference Plasma, Abnormal cleared by the FDA?
Coagulation Reference Plasma, Abnormal (K904073) received a 510(k) decision of Substantially Equivalent on October 22, 1990, 47 days after the submission was received.
What is the product code of K904073?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.