Sulfate, Fibriquik Protamine
FDA 510(k) K781814 · General Diagnostics
510(k) numberK781814
Submission
- Device name
- Sulfate, Fibriquik Protamine
- Applicant
- General Diagnostics
Mchenry, IL, US - Received
- October 26, 1978
- Decision date
- November 8, 1978
- 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 |
|---|---|---|---|
| K854015 | FS Test KitJBN · Traditional | American Bioproducts Co. | 03/06/1986SE |
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| K864993 | Quali. Enzyme Immuno. of Barbiturates in UrineDIS · Traditional | 03/31/1987SE |
| K863877 | Benzodiazepine Enzyme Immunoassay KitJXM · Traditional | 03/12/1987SE |
| K842307 | General Diag. Cefonicid 30MCG AntimicJTN · Traditional | 07/20/1984SE |
| K841465 | General Diagnostics Platelet AntibodyLLG · Traditional | 07/02/1984SE |
| K833709 | Ceftizoxime 30 MCG Antimicrobial DiskJTN · Traditional | 12/30/1983SE |
| K832653 | Cefuroxime 30MCG. Suscep DiskJTN · Traditional | 10/14/1983SE |
| K831179 | Cefazolin 30MCG. Antimicrobial SuscepJTN · Traditional | 05/09/1983SE |
Questions and answers
When was Sulfate, Fibriquik Protamine cleared by the FDA?
Sulfate, Fibriquik Protamine (K781814) received a 510(k) decision of Substantially Equivalent on November 8, 1978, 13 days after the submission was received.
What is the product code of K781814?
The FDA product code is JBN – Fibrin Monomer Paracoagulation, a Class II (moderate risk) device regulated under 21 CFR 864.7300.