FDA Product Code
FDA Product Code JIR — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1645
510(k) Clearances — 38 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K222921 | Minuteful-kidney test | Healthy.Io, Ltd. | 2023-09-08 | Traditional | PDF ↗ |
| K210069 | Minuteful - kidney test | Healthy.Io, Ltd. | 2022-07-06 | Traditional | PDF ↗ |
| K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) | ACON Laboratories, Inc. | 2015-04-30 | Traditional | PDF ↗ |
| K061419 | TECO MICROALBUMIN 2-1 COMBO STRIPS | Teco Diagnostics | 2007-01-26 | Traditional | PDF ↗ |
| K022538 | IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 | Diagnostic Chemicals, Ltd. (Usa) | 2002-08-23 | Special | PDF ↗ |
| K001810 | URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING | Flexsite Diagnostics, Inc. | 2000-08-14 | Traditional | PDF ↗ |
| K994035 | IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 | Diagnostic Chemicals , Ltd. | 2000-02-01 | Traditional | PDF ↗ |
| K992257 | NEW MULTIPLES REAGENT STRIPS | Bayer Corp. | 1999-11-24 | Traditional | PDF ↗ |
| K991315 | MICROALBUSTIX REAGENT STRIPS (OTC) | Bayer Corp. | 1999-11-12 | Traditional | PDF ↗ |
| K983774 | UALB | Abbott Laboratories | 1999-01-28 | Traditional | PDF ↗ |
| K972960 | HEALTH CHECK URI-TEST PROTEIN IN URINE | Tcpi, Inc. | 1998-10-07 | Traditional | PDF ↗ |
| K982219 | MICROALBUSTIX REAGENT STRIPS | Bayer Corp. | 1998-08-12 | Traditional | PDF ↗ |
| K972337 | DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA | Diagnostic Chemicals , Ltd. | 1997-08-08 | Traditional | PDF ↗ |
| K970932 | ORGENTEC MICRO-ALBUMIN EIA ASSAY | American Laboratory Products Co., Ltd. | 1997-04-08 | Traditional | PDF ↗ |
| K963142 | DCA 2000 + MICROALBUMIN/CREATININE ASSAY | Bayer Corp. | 1996-09-27 | Traditional | PDF ↗ |
| K951222 | TOTAL PROTEIN (URINE) | Randox Laboratories, Ltd. | 1996-04-24 | Traditional | PDF ↗ |
| K960274 | ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY | Orgentec | 1996-03-29 | Traditional | PDF ↗ |
| K955438 | URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) | Teco Diagnostics | 1996-01-29 | Traditional | PDF ↗ |
| K954346 | CHEMSTRIP MICRAL URINE TEST STRIPS | Boehringer Mannheim Corp. | 1995-10-26 | Traditional | PDF ↗ |
| K932950 | TINA-QUANT MICROALBUMIN | Boehringer Mannheim Corp. | 1995-02-10 | Traditional | PDF ↗ |
| K934146 | N-ASSAY TIA MICROALBUMIN | Crestat Diagnostics, Inc. | 1994-01-11 | Traditional | PDF ↗ |
| K922032 | ENZIP URINARY MICROALBUMIN TEST | Diagnostic Specialties | 1992-07-30 | Traditional | PDF ↗ |
| K920216 | SYN ELISA MICRO ALBUMIN | Elias U.S.A., Inc. | 1992-03-11 | Traditional | PDF ↗ |
| K912246 | TARGET MICROALBUMINURIA TEST | Texas Immunology, Inc. | 1991-07-19 | Traditional | PDF ↗ |
| K912543 | MICRO ALBUMIN EIA TEST KIT | Immuno Diagnostic Center, Inc. | 1991-07-19 | Traditional | PDF ↗ |
| K904752 | CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS | Boehringer Mannheim Corp. | 1991-04-12 | Traditional | PDF ↗ |
| K902204 | STANBIO CSF/URINE TOTAL PROTEIN TEST SET | Stanbio Laboratory | 1990-08-22 | Traditional | PDF ↗ |
| K896440 | KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT | Kenlor Industries, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K894169 | BIOTEL MICROALBUMINURIA (TM) | American Diagnostic Corp. | 1989-09-18 | Traditional | PDF ↗ |
| K891544 | DIALBUMIN | Exocell, Inc. | 1989-06-09 | Traditional | PDF ↗ |
| K890846 | BIOTROL URINE PROTEINS REAGENT | Biotrol, USA, Inc. | 1989-03-21 | Traditional | PDF ↗ |
| K882538 | PROGENE MICROALBUMINURIA SCREEN | Progene Corp. | 1989-03-13 | Traditional | PDF ↗ |
| K885053 | BIOTROL URINE PROTEINS REAGENT | Biotrol, USA, Inc. | 1989-01-30 | Traditional | PDF ↗ |
| K884146 | ALBUWELL | Exocell, Inc. | 1989-01-23 | Traditional | PDF ↗ |
| K874909 | MICRO-BUMINTEST REAGENT TABLETS | Miles Laboratories, Inc. | 1988-04-28 | Traditional | PDF ↗ |
| K851338 | DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI | Diagnostic Products Corp. | 1986-04-07 | Traditional | PDF ↗ |
| K830977 | HELENA BIOSTRIP P | Helena Laboratories | 1983-04-28 | Traditional | PDF ↗ |
| K811219 | KOVA STRIP 6 | Icl Scientific | 1981-05-21 | Traditional | PDF ↗ |
Product code JIR · Class I · Clinical Chemistry. Data: openFDA.