Q.I.C. Bleeding Time Device
FDA 510(k) K871318 · Helena Laboratories
510(k) numberK871318
Submission
- Device name
- Q.I.C. Bleeding Time Device
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- April 3, 1987
- Decision date
- June 10, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K911745 | Simplate PediatricJCA · Traditional | Organon Teknika Corp. | 08/09/1991SE |
| K911996 | Surgicutt-Bleeding Time Device, ModificationJCA · Traditional | International Technidyne Corp. | 07/17/1991SE |
| 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 |
More from General Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K213396 | SPIFE A1AT kitOBZ · Traditional | 10/13/2022SE |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlGKA · Traditional | 04/19/2022SE |
| K131479 | V8 SP Normal Control, Abnormal ControlJJY · Traditional | 10/07/2013SE |
| K100103 | Specialty Assayed CONTROL-2GGC · Traditional | 12/15/2010SE |
| K061991 | Plateletworks Arachidonic Acid, Model Pw-AcaGHR · Traditional | 02/23/2007SE |
| K061069 | Spife IFE-15 Pentavalent, Model 3456, Spife IFE-9 Pentavalent Kit, Model 3457, Spift…CFF · Traditional | 07/06/2006SE |
| K061014 | Actalyke QC Kit, Models Aqc-Hp and Aqc-LpJPA · Special | 05/10/2006SE |
| K050053 | Hemoram/Aggram AnalyzerJPA · Traditional | 07/11/2005SE |
| K024162 | Spife 3000 Titan Gel Igg Ief Kit, Model 3389CFF · Traditional | 02/19/2003SE |
| K023761 | Plateletworks, Models Pw-A, Pw-CJOZ · Traditional | 02/14/2003SE |
Questions and answers
When was Q.I.C. Bleeding Time Device cleared by the FDA?
Q.I.C. Bleeding Time Device (K871318) received a 510(k) decision of Substantially Equivalent on June 10, 1987, 68 days after the submission was received.
What is the product code of K871318?
The FDA product code is JCA – Device, Bleeding Time, a Class II (moderate risk) device regulated under 21 CFR 864.6100.