Helena Thromboplastin Reagent, Modification
FDA 510(k) K905857 · Helena Laboratories
510(k) numberK905857
Submission
- Device name
- Helena Thromboplastin Reagent, Modification
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- December 14, 1990
- Decision date
- February 27, 1991
- 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 |
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Questions and answers
When was Helena Thromboplastin Reagent, Modification cleared by the FDA?
Helena Thromboplastin Reagent, Modification (K905857) received a 510(k) decision of Substantially Equivalent on February 27, 1991, 75 days after the submission was received.
What is the product code of K905857?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.