Hbpm/Lmwh Control Kit
FDA 510(k) K943519 · American Bioproducts Co.
510(k) numberK943519
Submission
- Device name
- Hbpm/Lmwh Control Kit
- Applicant
- American Bioproducts Co.
Parisppany, NJ, US - Received
- July 21, 1994
- Decision date
- September 26, 1995
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KFF – Assay, Heparin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7525
- Specialty
- Hematology
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| 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 Hbpm/Lmwh Control Kit cleared by the FDA?
Hbpm/Lmwh Control Kit (K943519) received a 510(k) decision of Unknown on September 26, 1995, 432 days after the submission was received.
What is the product code of K943519?
The FDA product code is KFF – Assay, Heparin, a Class II (moderate risk) device regulated under 21 CFR 864.7525.