Coag-A-Mate(R) XM
FDA 510(k) K881281 · Organon Teknika Corp.
510(k) numberK881281
Submission
- Device name
- Coag-A-Mate(R) XM
- Applicant
- Organon Teknika Corp.
Durham, NC, US - Received
- March 25, 1988
- Decision date
- May 18, 1988
- 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 Coag-A-Mate(R) XM cleared by the FDA?
Coag-A-Mate(R) XM (K881281) received a 510(k) decision of Substantially Equivalent on May 18, 1988, 54 days after the submission was received.
What is the product code of K881281?
The FDA product code is GKP – Instrument, Coagulation, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5400.