Target Microalbuminuria Test
FDA 510(k) K912246 · Texas Immunology, Inc.
510(k) numberK912246
Submission
- Device name
- Target Microalbuminuria Test
- Applicant
- Texas Immunology, Inc.
Tyler, TX, US - Received
- May 21, 1991
- Decision date
- July 19, 1991
- 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 Target Microalbuminuria Test cleared by the FDA?
Target Microalbuminuria Test (K912246) received a 510(k) decision of Substantially Equivalent on July 19, 1991, 59 days after the submission was received.
What is the product code of K912246?
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.