Dade Factor Viii Chromogenic Assay
FDA 510(k) K884544 · Baxter Healthcare Corp
510(k) numberK884544
Submission
- Device name
- Dade Factor Viii Chromogenic Assay
- Applicant
- Baxter Healthcare Corp
Miami, FL, US - Received
- October 31, 1988
- Decision date
- December 30, 1988
- 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 Dade Factor Viii Chromogenic Assay cleared by the FDA?
Dade Factor Viii Chromogenic Assay (K884544) received a 510(k) decision of Substantially Equivalent on December 30, 1988, 60 days after the submission was received.
What is the product code of K884544?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.