FS Test Kit
FDA 510(k) K854015 · American Bioproducts Co.
510(k) numberK854015
Submission
- Device name
- FS Test Kit
- Applicant
- American Bioproducts Co.
Parsippany, NJ, US - Received
- September 27, 1985
- Decision date
- March 6, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JBN – Fibrin Monomer Paracoagulation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7300
- Specialty
- Hematology
Other 510(k)s with product code JBN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K781814 | Sulfate, Fibriquik ProtamineJBN · Traditional | General Diagnostics | 11/08/1978SE |
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Questions and answers
When was FS Test Kit cleared by the FDA?
FS Test Kit (K854015) received a 510(k) decision of Substantially Equivalent on March 6, 1986, 160 days after the submission was received.
What is the product code of K854015?
The FDA product code is JBN – Fibrin Monomer Paracoagulation, a Class II (moderate risk) device regulated under 21 CFR 864.7300.