Asserachrom Protein C Kit
FDA 510(k) K854016 · American Bioproducts Co.
510(k) numberK854016
Submission
- Device name
- Asserachrom Protein C Kit
- Applicant
- American Bioproducts Co.
Parsippany, NJ, US - Received
- September 27, 1985
- Decision date
- January 3, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JLA – Conversion To Creatinine, Creatine
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1210
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JLA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K852767 | Erythocyte CreatineJLA · Traditional | Panmed, Inc. | 11/13/1986SE |
More from Panmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983460 | Star Automated Multi-Parametric AnalyzerJPA · Traditional | 11/12/1998SE |
| K971519 | Asserachrom Tpa Test KitGGP · Traditional | 08/19/1997SE |
| K964728 | Sta-Liatest D-Di Test KitDAP · Traditional | 06/26/1997SE |
| K964716 | Sta Liatest Control [N]+[P] KitGGN · Traditional | 06/26/1997SE |
| K964718 | Sta D-Di Calibrator KitDAP · Traditional | 05/23/1997SE |
| K962675 | Sta - Liatest VWF Test KitGJT · Traditional | 10/25/1996SE |
| K962671 | Sta-Vwf Calibrator KitGJT · Traditional | 09/13/1996SE |
| K962674 | Sta - VWF Control [N]+[P] KitGGN · Traditional | 07/23/1996SE |
| K961579 | Sta Compact Automated Multi-Parametric AnalyzerGKP · Traditional | 07/10/1996SE |
| K955040 | At-Iii Control Plasma KitGGC · Traditional | 01/31/1996SE |
Questions and answers
When was Asserachrom Protein C Kit cleared by the FDA?
Asserachrom Protein C Kit (K854016) received a 510(k) decision of Substantially Equivalent on January 3, 1986, 98 days after the submission was received.
What is the product code of K854016?
The FDA product code is JLA – Conversion To Creatinine, Creatine, a Class I (low risk) device regulated under 21 CFR 862.1210.