Thromboplastin with Calcium
FDA 510(k) K902096 · Sigma Chemical Co.
510(k) numberK902096
Submission
- Device name
- Thromboplastin with Calcium
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- May 8, 1990
- Decision date
- July 3, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GJS – Test, Time, Prothrombin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7750
- Specialty
- Hematology
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| K213426 | HemosIL ReadiPlasTinGJS · Traditional | Instrumentation Laboratory CO | 08/16/2022SE |
| K201185 | microINR SystemGJS · Traditional | Iline Microsystems, S.L. | 12/18/2020SE |
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| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
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Questions and answers
When was Thromboplastin with Calcium cleared by the FDA?
Thromboplastin with Calcium (K902096) received a 510(k) decision of Substantially Equivalent on July 3, 1990, 56 days after the submission was received.
What is the product code of K902096?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.