Orgentec Micro-Albumin Eia Assay
FDA 510(k) K970932 · American Laboratory Products Co., Ltd.
510(k) numberK970932
Submission
- Device name
- Orgentec Micro-Albumin Eia Assay
- Applicant
- American Laboratory Products Co., Ltd.
Windham, NH, US - Received
- February 20, 1997
- Decision date
- April 8, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1645
- Specialty
- Clinical Chemistry
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Questions and answers
When was Orgentec Micro-Albumin Eia Assay cleared by the FDA?
Orgentec Micro-Albumin Eia Assay (K970932) received a 510(k) decision of Substantially Equivalent on April 8, 1997, 47 days after the submission was received.
What is the product code of K970932?
The FDA product code is JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1645.