Protein C Antigen Rocket Eid Method No. 5357
FDA 510(k) K897136 · Helena Laboratories
510(k) numberK897136
Submission
- Device name
- Protein C Antigen Rocket Eid Method No. 5357
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- December 27, 1989
- Decision date
- February 5, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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Questions and answers
When was Protein C Antigen Rocket Eid Method No. 5357 cleared by the FDA?
Protein C Antigen Rocket Eid Method No. 5357 (K897136) received a 510(k) decision of Substantially Equivalent on February 5, 1990, 40 days after the submission was received.
What is the product code of K897136?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.