Arachidonic Acid
FDA 510(k) K912774 · Helena Laboratories
510(k) numberK912774
Submission
- Device name
- Arachidonic Acid
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- June 24, 1991
- Decision date
- August 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JBX – Aggregrometer, Platelet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6675
- Specialty
- Hematology
Other 510(k)s with product code JBX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932566 | Aggro/Link Control SoftwareJBX · Traditional | Chrono-Log Corp. | 11/02/1993SE |
| K881829 | Pat Platelet Aggregation TestJBX · Traditional | Streck Laboratories, Inc. | 07/01/1988SE |
| K862775 | Asserachrom B-Tg KitJBX · Traditional | American Bioproducts Co. | 10/22/1986SE |
| K851025 | Aggro/Link Computer InterfaceJBX · Traditional | Chrono-Log Corp. | 06/12/1985SE |
| K850592 | Platelet Aggregation ReagentJBX · Traditional | Chrono-Log Corp. | 05/13/1985SE |
| K832929 | Ristocetin Platelet Aggrega-Reagent TestJBX · Traditional | Sigma Chemical Co. | 09/29/1983SE |
| K830749 | Platelet AggregometerJBX · Traditional | Chrono-Log Corp. | 05/16/1983SE |
| K821005 | Platelet Aggregation Profiler #PAP-4JBX · Traditional | Bio/Data Corp. | 06/01/1982SE |
| K811290 | Arachidonic AcidJBX · Traditional | Bio/Data Corp. | 07/27/1981SE |
| K781710 | Buffer, Collagen Reagent and DiluentJBX · Traditional | Diagnostica, Inc. | 10/24/1978SE |
More from Diagnostica, Inc.
| 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 Arachidonic Acid cleared by the FDA?
Arachidonic Acid (K912774) received a 510(k) decision of Substantially Equivalent on August 22, 1991, 59 days after the submission was received.
What is the product code of K912774?
The FDA product code is JBX – Aggregrometer, Platelet, a Class II (moderate risk) device regulated under 21 CFR 864.6675.