Koagulab 60-S Coagulation System
FDA 510(k) K901120 · Ortho Diagnostic Systems, Inc.
510(k) numberK901120
Submission
- Device name
- Koagulab 60-S Coagulation System
- Applicant
- Ortho Diagnostic Systems, Inc.
Raritan, NJ, US - Received
- March 12, 1990
- Decision date
- May 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKP – Instrument, Coagulation, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5400
- Specialty
- Hematology
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Questions and answers
When was Koagulab 60-S Coagulation System cleared by the FDA?
Koagulab 60-S Coagulation System (K901120) received a 510(k) decision of Substantially Equivalent on May 22, 1990, 71 days after the submission was received.
What is the product code of K901120?
The FDA product code is GKP – Instrument, Coagulation, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5400.