Simplate Pediatric
FDA 510(k) K911745 · Organon Teknika Corp.
510(k) numberK911745
Submission
- Device name
- Simplate Pediatric
- Applicant
- Organon Teknika Corp.
Durham, NC, US - Received
- April 18, 1991
- Decision date
- August 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JCA – Device, Bleeding Time
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6100
- Specialty
- Hematology
Other 510(k)s with product code JCA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K911996 | Surgicutt-Bleeding Time Device, ModificationJCA · Traditional | International Technidyne Corp. | 07/17/1991SE |
| K871318 | Q.I.C. Bleeding Time DeviceJCA · Traditional | Helena Laboratories | 06/10/1987SE |
| K850542 | Surgicutt - Bleeding Time DeviceJCA · Traditional | International Technidyne Corp. | 03/01/1985SE |
| K830645 | Bleeding Time Device DisposableJCA · Traditional | American Dade | 03/17/1983SE |
| K801815 | AutoletJCA · Traditional | Ulster Scientific, Inc. | 10/10/1980SE |
| K761250 | SimplateJCA · Traditional | General Diagnostics | 03/01/1977SE |
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Questions and answers
When was Simplate Pediatric cleared by the FDA?
Simplate Pediatric (K911745) received a 510(k) decision of Substantially Equivalent on August 9, 1991, 113 days after the submission was received.
What is the product code of K911745?
The FDA product code is JCA – Device, Bleeding Time, a Class II (moderate risk) device regulated under 21 CFR 864.6100.