Simplastin Excel S
FDA 510(k) K882214 · Organon Teknika Corp.
510(k) numberK882214
Submission
- Device name
- Simplastin Excel S
- Applicant
- Organon Teknika Corp.
Durham, NC, US - Received
- May 26, 1988
- Decision date
- July 1, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GJS – Test, Time, Prothrombin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7750
- Specialty
- Hematology
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| K213426 | HemosIL ReadiPlasTinGJS · Traditional | Instrumentation Laboratory CO | 08/16/2022SE |
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Questions and answers
When was Simplastin Excel S cleared by the FDA?
Simplastin Excel S (K882214) received a 510(k) decision of Substantially Equivalent on July 1, 1988, 36 days after the submission was received.
What is the product code of K882214?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.