Enzip Urinary Microalbumin Test
FDA 510(k) K922032 · Diagnostic Specialties
510(k) numberK922032
Submission
- Device name
- Enzip Urinary Microalbumin Test
- Applicant
- Diagnostic Specialties
Metuchen, NJ, US - Received
- May 1, 1992
- Decision date
- July 30, 1992
- 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
Other 510(k)s with product code JIR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222921 | Minuteful-kidney testJIR · Traditional | Healthy.Io, Ltd. | 09/08/2023SE |
| K210069 | Minuteful - kidney testJIR · Traditional | Healthy.Io, Ltd. | 07/06/2022SE |
| K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)JIR · Traditional | ACON Laboratories, Inc. | 04/30/2015SE |
| 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 |
| K994035 | Immunodip Urinary Albumin Screen, Model 790-01, 790-15JIR · Traditional | Diagnostic Chemicals , Ltd. | 02/01/2000SE |
| 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 |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K971458 | Enzip Immunoturbidimetric Microalbumin Assay KitJIQ · Traditional | 09/02/1997SE |
| K941001 | Enzip Immunoturbidmetric Fibrinogen Assay KitGIS · Traditional | 08/30/1994SE |
| K930823 | Protein-Bound Glucose Assayn KitLCP · Traditional | 08/19/1993SE |
| K831180 | Pregna-Cert, Slide Pregnancy TestJHJ · Traditional | 05/27/1983SE |
| K823109 | Generic Pregnancy TestLCX · Traditional | 11/10/1982SE |
| K813608 | Potassium Reagent SetCEJ · Traditional | 01/22/1982SE |
| K813412 | Glucose Enzyme-Color Reagent SetCGA · Traditional | 12/31/1981SE |
Questions and answers
When was Enzip Urinary Microalbumin Test cleared by the FDA?
Enzip Urinary Microalbumin Test (K922032) received a 510(k) decision of Substantially Equivalent on July 30, 1992, 90 days after the submission was received.
What is the product code of K922032?
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.