Immunodip Urinary Albumin Screen, Model 790-01, 790-15
FDA 510(k) K994035 · Diagnostic Chemicals , Ltd.
510(k) numberK994035
Submission
- Device name
- Immunodip Urinary Albumin Screen, Model 790-01, 790-15
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E., CA - Received
- November 29, 1999
- Decision date
- February 1, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K061419 | Teco Microalbumin 2-1 Combo StripsJIR · Traditional | Teco Diagnostics | 01/26/2007SE |
| K022538 | Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25JIR · Special | Diagnostic Chemicals, Ltd. (Usa) | 08/23/2002SE |
| K001810 | Urisite Urine Collection Kit for Microalbumin/Creatinine TestingJIR · Traditional | Flexsite Diagnostics, Inc. | 08/14/2000SE |
| K992257 | New Multiples Reagent StripsJIR · Traditional | Bayer Corp. | 11/24/1999SE |
| K991315 | Microalbustix Reagent Strips (OTC)JIR · Traditional | Bayer Corp. | 11/12/1999SE |
| K983774 | UalbJIR · Traditional | Abbott Laboratories | 01/28/1999SE |
| K972960 | Health Check Uri-Test Protein in UrineJIR · Traditional | Tcpi, Inc. | 10/07/1998SE |
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| K051757 | Calcium Advance Assay, Model 145-20, 145-25, 145-20-91CJY · Traditional | 11/10/2005SE |
| K051191 | DCL Microalbumin Assay, Model 252-20DCF · Traditional | 07/05/2005SE |
| K042330 | Acetaminophen-Sl AssayLDP · Traditional | 01/07/2005SE |
| K042362 | Modification to Carbon DIOXIDE-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and…KHS · Traditional | 12/27/2004SE |
| K042329 | Salicylate-Sl AssayDKJ · Traditional | 12/27/2004SE |
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Questions and answers
When was Immunodip Urinary Albumin Screen, Model 790-01, 790-15 cleared by the FDA?
Immunodip Urinary Albumin Screen, Model 790-01, 790-15 (K994035) received a 510(k) decision of Substantially Equivalent on February 1, 2000, 64 days after the submission was received.
What is the product code of K994035?
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.