Dade(R) Alpha 2 ANTIPLASMIN(2 2-AP) Chromo Assay
FDA 510(k) K914818 · Baxter Diagnostics, Inc.
510(k) numberK914818
Submission
- Device name
- Dade(R) Alpha 2 ANTIPLASMIN(2 2-AP) Chromo Assay
- Applicant
- Baxter Diagnostics, Inc.
Miami, FL, US - Received
- October 25, 1991
- Decision date
- January 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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(R) Alpha 2 ANTIPLASMIN(2 2-AP) Chromo Assay cleared by the FDA?
Dade(R) Alpha 2 ANTIPLASMIN(2 2-AP) Chromo Assay (K914818) received a 510(k) decision of Substantially Equivalent on January 15, 1992, 82 days after the submission was received.
What is the product code of K914818?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.