Panels › Clinical Chemistry › Product code JIR · Class 1
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Regulation 862.1645
0510(k)s in 12 months (38 all time)
4recalls in 12 months (7 all time)
1recalls that name a 510(k)
Top companies in JIR
| Company | 510(k)s | Recalls |
|---|---|---|
| Bayer Corp. | 4 | 0 |
| Siemens Healthcare Diagnostics, Inc. | 0 | 4 |
| Boehringer Mannheim Corp. | 3 | 0 |
| Diagnostic Chemicals , Ltd. | 3 | 0 |
| Biotrol, USA, Inc. | 2 | 0 |
| Exocell, Inc. | 2 | 0 |
| Healthy.Io, Ltd. | 2 | 0 |
| Teco Diagnostics | 2 | 0 |
| Abbott Laboratories | 1 | 0 |
| ACON Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 2023 | K222921 | Minuteful-kidney test Healthy.Io, Ltd., IL | JIR |
| Jul 6, 2022 | K210069 | Minuteful - kidney test Healthy.Io, Ltd., IL | JIR |
| Apr 30, 2015 | K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) ACON Laboratories, Inc. | JIR |
| Jan 26, 2007 | K061419 | TECO MICROALBUMIN 2-1 COMBO STRIPS Teco Diagnostics | JIR |
| Aug 23, 2002 | K022538 | IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 Diagnostic Chemicals, Ltd. (Usa) | JIR |
| Aug 14, 2000 | K001810 | URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING Flexsite Diagnostics, Inc. | JIR |
| Feb 1, 2000 | K994035 | IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 Diagnostic Chemicals , Ltd., CA | JIR |
| Nov 24, 1999 | K992257 | NEW MULTIPLES REAGENT STRIPS Bayer Corp. | JIR |
| Nov 12, 1999 | K991315 | MICROALBUSTIX REAGENT STRIPS (OTC) Bayer Corp. | JIR |
| Jan 28, 1999 | K983774 | UALB Abbott Laboratories | JIR |
| Oct 7, 1998 | K972960 | HEALTH CHECK URI-TEST PROTEIN IN URINE Tcpi, Inc. | JIR |
| Aug 12, 1998 | K982219 | MICROALBUSTIX REAGENT STRIPS Bayer Corp. | JIR |
| Aug 8, 1997 | K972337 | DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA Diagnostic Chemicals , Ltd., CA | JIR |
| Apr 8, 1997 | K970932 | ORGENTEC MICRO-ALBUMIN EIA ASSAY American Laboratory Products Co., Ltd. | JIR |
| Sep 27, 1996 | K963142 | DCA 2000 + MICROALBUMIN/CREATININE ASSAY Bayer Corp. | JIR |
| Apr 24, 1996 | K951222 | TOTAL PROTEIN (URINE) Randox Laboratories, Ltd., IE | JIR |
| Mar 29, 1996 | K960274 | ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY Orgentec | JIR |
| Jan 29, 1996 | K955438 | URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) Teco Diagnostics | JIR |
| Oct 26, 1995 | K954346 | CHEMSTRIP MICRAL URINE TEST STRIPS Boehringer Mannheim Corp. | JIR |
| Feb 10, 1995 | K932950 | TINA-QUANT MICROALBUMIN Boehringer Mannheim Corp. | JIR |
| Jan 11, 1994 | K934146 | N-ASSAY TIA MICROALBUMIN Crestat Diagnostics, Inc. | JIR |
| Jul 30, 1992 | K922032 | ENZIP URINARY MICROALBUMIN TEST Diagnostic Specialties | JIR |
| Mar 11, 1992 | K920216 | SYN ELISA MICRO ALBUMIN Elias U.S.A., Inc. | JIR |
| Jul 19, 1991 | K912543 | MICRO ALBUMIN EIA TEST KIT Immuno Diagnostic Center, Inc. | JIR |
| Jul 19, 1991 | K912246 | TARGET MICROALBUMINURIA TEST Texas Immunology, Inc. | JIR |
| Apr 12, 1991 | K904752 | CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS Boehringer Mannheim Corp. | JIR |
| Aug 22, 1990 | K902204 | STANBIO CSF/URINE TOTAL PROTEIN TEST SET Stanbio Laboratory | JIR |
| Feb 16, 1990 | K896440 | KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT Kenlor Industries, Inc. | JIR |
| Sep 18, 1989 | K894169 | BIOTEL MICROALBUMINURIA (TM) American Diagnostic Corp. | JIR |
| Jun 9, 1989 | K891544 | DIALBUMIN Exocell, Inc. | JIR |
| Mar 21, 1989 | K890846 | BIOTROL URINE PROTEINS REAGENT Biotrol, USA, Inc. | JIR |
| Mar 13, 1989 | K882538 | PROGENE MICROALBUMINURIA SCREEN Progene Corp. | JIR |
| Jan 30, 1989 | K885053 | BIOTROL URINE PROTEINS REAGENT Biotrol, USA, Inc. | JIR |
| Jan 23, 1989 | K884146 | ALBUWELL Exocell, Inc. | JIR |
| Apr 28, 1988 | K874909 | MICRO-BUMINTEST REAGENT TABLETS Miles Laboratories, Inc. | JIR |
| Apr 7, 1986 | K851338 | DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI Diagnostic Products Corp. | JIR |
| Apr 28, 1983 | K830977 | HELENA BIOSTRIP P Helena Laboratories | JIR |
| May 21, 1981 | K811219 | KOVA STRIP 6 Icl Scientific | JIR |
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