Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25
FDA 510(k) K022538 · Diagnostic Chemicals, Ltd. (Usa)
510(k) numberK022538
Submission
- Device name
- Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
Laguna Hills, CA, US - Received
- August 1, 2002
- Decision date
- August 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K932555 | Dc-Lineate Cat. No. SE-091JIS · Traditional | 08/19/1993SE |
| K925877 | Dc-Uibc-CalJIS · Traditional | 03/18/1993SE |
| K912825 | Magnesium Assay Kit, Cat.# 100-12JGJ · Traditional | 07/26/1991SE |
| K895964 | DCL Syphilis-M Catalog No. 600-80LIP · Traditional | 01/08/1991SE |
| K895965 | DCL - Syphilis-G Assay Catalog No. 600-70LIP · Traditional | 12/26/1990SE |
| K904660 | Enzymatic Bilirubin (Total), Catalogue No. 202-14JFM · Traditional | 11/20/1990SE |
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Questions and answers
When was Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25 cleared by the FDA?
Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25 (K022538) received a 510(k) decision of Substantially Equivalent on August 23, 2002, 22 days after the submission was received.
What is the product code of K022538?
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.