Collagen Reagent Cat. No. 5368
FDA 510(k) K910706 · Helena Laboratories
510(k) numberK910706
Submission
- Device name
- Collagen Reagent Cat. No. 5368
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- February 20, 1991
- Decision date
- May 20, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GHR – Reagent, Platelet Aggregation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5700
- Specialty
- Hematology
Other 510(k)s with product code GHR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061991 | Plateletworks Arachidonic Acid, Model Pw-AcaGHR · Traditional | Helena Laboratories | 02/23/2007SE |
| K952252 | Adp Reagent, ModifiedGHR · Traditional | Helena Laboratories | 09/08/1995SE |
| K922800 | Platelet Aggregation ReagentsGHR · Traditional | Chrono-Log Corp. | 08/26/1992SE |
| K910800 | Adp ReagentGHR · Traditional | Helena Laboratories | 05/20/1991SE |
| K910680 | Epinephrine Reagent, Cat. No. 5367GHR · Traditional | Helena Laboratories | 05/20/1991SE |
| K910286 | Platelet Aggregation ReagentsGHR · Traditional | Medical Diagnostic Technologies, Inc. | 03/19/1991SE |
| K900792 | RistocetinGHR · Traditional | Medical Diagnostic Technologies, Inc. | 03/27/1990SE |
| K832428 | Platelet Aggregation Reagent SetGHR · Traditional | Helena Laboratories | 10/20/1983SE |
| K820422 | Platelet AggregometersGHR · Traditional | Chrono-Log Corp. | 03/16/1982SE |
| K760198 | Kit, Platelet Aggregation Reagent (#390)GHR · Traditional | Chrono-Log Corp. | 07/19/1976SE |
More from Chrono-Log Corp.
| 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 Collagen Reagent Cat. No. 5368 cleared by the FDA?
Collagen Reagent Cat. No. 5368 (K910706) received a 510(k) decision of Substantially Equivalent on May 20, 1991, 89 days after the submission was received.
What is the product code of K910706?
The FDA product code is GHR – Reagent, Platelet Aggregation, a Class II (moderate risk) device regulated under 21 CFR 864.5700.