JIR — Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Class I
FDA product code JIR covers "Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)", a Class I medical device regulated under 21 CFR 862.1645. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JIR
- Device Class
- Class I
- Regulation Number
- 862.1645
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K222921 | healthy.io | Minuteful-kidney test | September 8, 2023 |
| K210069 | healthy.io | Minuteful - kidney test | July 6, 2022 |
| K150330 | acon laboratories | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) | April 30, 2015 |
| K061419 | teco diagnostics | TECO MICROALBUMIN 2-1 COMBO STRIPS | January 26, 2007 |
| K022538 | diagnostic chemicals, ltd. (usa) | IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 | August 23, 2002 |
| K001810 | flexsite diagnostics | URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING | August 14, 2000 |
| K994035 | diagnostic chemicals | IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 | February 1, 2000 |
| K992257 | bayer | NEW MULTIPLES REAGENT STRIPS | November 24, 1999 |
| K991315 | bayer | MICROALBUSTIX REAGENT STRIPS (OTC) | November 12, 1999 |
| K983774 | abbott laboratories | UALB | January 28, 1999 |
| K972960 | tcpi | HEALTH CHECK URI-TEST PROTEIN IN URINE | October 7, 1998 |
| K982219 | bayer | MICROALBUSTIX REAGENT STRIPS | August 12, 1998 |
| K972337 | diagnostic chemicals | DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA | August 8, 1997 |
| K970932 | american laboratory products co | ORGENTEC MICRO-ALBUMIN EIA ASSAY | April 8, 1997 |
| K963142 | bayer | DCA 2000 + MICROALBUMIN/CREATININE ASSAY | September 27, 1996 |
| K951222 | randox laboratories | TOTAL PROTEIN (URINE) | April 24, 1996 |
| K960274 | orgentec | ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY | March 29, 1996 |
| K955438 | teco diagnostics | URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) | January 29, 1996 |
| K954346 | boehringer mannheim | CHEMSTRIP MICRAL URINE TEST STRIPS | October 26, 1995 |
| K932950 | boehringer mannheim | TINA-QUANT MICROALBUMIN | February 10, 1995 |