Antithrombin III Serum, Anti-Human
FDA 510(k) K781026 · Icl Scientific
510(k) numberK781026
Submission
- Device name
- Antithrombin III Serum, Anti-Human
- Applicant
- Icl Scientific
Mchenry, IL, US - Received
- June 19, 1978
- Decision date
- August 10, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JBQ – Antithrombin Iii Quantitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7060
- Specialty
- Hematology
Other 510(k)s with product code JBQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242952 | INNOVANCE AntithrombinJBQ · Traditional | Siemens Healthcare Diagnostic Products GmbH | 03/28/2025SE |
| K081769 | Innovance Antithrombin with Models OPFH03, OPFHO5JBQ · Traditional | Siemens Healthcare Diagnostics | 05/28/2009SE |
| K070301 | Hemosil AntithrombinJBQ · Special | Instrumentation Laboratory CO | 02/23/2007SE |
| K062431 | Hemosil Liquid AntithrombinJBQ · Special | Instrumentation Laboratory CO | 09/01/2006SE |
| K043007 | Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105JBQ · Traditional | Hyphen Biomed | 11/07/2005SE |
| K033775 | Hemosil Liquid Antithrombin XLJBQ · Special | Instrumentation Laboratory CO | 01/02/2004SE |
| K023991 | Chromocheck Antithrombin 25; Chromocheck Antithrombin 50JBQ · Traditional | Precision Biologic | 04/28/2003SE |
| K022550 | Coamatic LR Antithrombin, Note: Lr=Liquid ReagentsJBQ · Traditional | Instrumentation Laboratory CO | 08/27/2002SE |
| K022195 | Coamatic AT-400JBQ · Traditional | Instrumentation Laboratory CO | 08/07/2002SE |
| K994238 | Il Test Liquid AntithrombinJBQ · Traditional | Instrumentation Laboratory CO | 06/23/2000SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K883942 | Hycor Sentry Drugs of Abuse Urine ControlJJY · Traditional | 11/10/1988SE |
| K843565 | Kova Trol I,Ii, III Human Urine-DriedJJW · Traditional | 10/05/1984SE |
| K833761 | Therapeutic Drug ControlDKB · Traditional | 01/13/1984SE |
| K832823 | Enzymune-Test TSHJLW · Traditional | 10/14/1983SE |
| K831383 | Event-Test SlideJHJ · Traditional | 06/22/1983SE |
| K823199 | Enzyme-Test DigoxinKXT · Traditional | 11/29/1982SE |
| K822777 | Therapeutic Drug ControlDIF · Traditional | 10/08/1982SE |
| K822346 | Histimune Enzyme-Ana TestLJM · Traditional | 10/08/1982SE |
| K822465 | Enzymune System IJJE · Traditional | 09/14/1982SE |
| K821374 | Enzymune-Test InsulinCFP · Traditional | 05/28/1982SE |
Questions and answers
When was Antithrombin III Serum, Anti-Human cleared by the FDA?
Antithrombin III Serum, Anti-Human (K781026) received a 510(k) decision of Substantially Equivalent on August 10, 1978, 52 days after the submission was received.
What is the product code of K781026?
The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.