Atlas FDA

JIR

38 FDA 510(k) clearances · Product code

90 daysmedian time to decision
401 days90th percentile
38clearances measured

FDA profile

Official device name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Device class
Class I (low risk)
Regulation
21 CFR 862.1645
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2013: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Minuteful-kidney test (K222921)Healthy.Io, Ltd.2023-09-08
Minuteful - kidney test (K210069)Healthy.Io, Ltd.2022-07-06
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (K150330)ACON Laboratories, Inc.2015-04-30
TECO MICROALBUMIN 2-1 COMBO STRIPS (K061419)Teco Diagnostics2007-01-26
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (K022538)Diagnostic Chemicals, Ltd. (Usa)2002-08-23
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING (K001810)Flexsite Diagnostics, Inc.2000-08-14
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 (K994035)Diagnostic Chemicals , Ltd.2000-02-01
NEW MULTIPLES REAGENT STRIPS (K992257)Bayer Corp.1999-11-24
MICROALBUSTIX REAGENT STRIPS (OTC) (K991315)Bayer Corp.1999-11-12
UALB (K983774)Abbott Laboratories1999-01-28
HEALTH CHECK URI-TEST PROTEIN IN URINE (K972960)Tcpi, Inc.1998-10-07
MICROALBUSTIX REAGENT STRIPS (K982219)Bayer Corp.1998-08-12
DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA (K972337)Diagnostic Chemicals , Ltd.1997-08-08
ORGENTEC MICRO-ALBUMIN EIA ASSAY (K970932)American Laboratory Products Co., Ltd.1997-04-08
DCA 2000 + MICROALBUMIN/CREATININE ASSAY (K963142)Bayer Corp.1996-09-27
TOTAL PROTEIN (URINE) (K951222)Randox Laboratories, Ltd.1996-04-24
ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY (K960274)Orgentec1996-03-29
URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) (K955438)Teco Diagnostics1996-01-29
CHEMSTRIP MICRAL URINE TEST STRIPS (K954346)Boehringer Mannheim Corp.1995-10-26
TINA-QUANT MICROALBUMIN (K932950)Boehringer Mannheim Corp.1995-02-10
N-ASSAY TIA MICROALBUMIN (K934146)Crestat Diagnostics, Inc.1994-01-11
ENZIP URINARY MICROALBUMIN TEST (K922032)Diagnostic Specialties1992-07-30
SYN ELISA MICRO ALBUMIN (K920216)Elias U.S.A., Inc.1992-03-11
MICRO ALBUMIN EIA TEST KIT (K912543)Immuno Diagnostic Center, Inc.1991-07-19
TARGET MICROALBUMINURIA TEST (K912246)Texas Immunology, Inc.1991-07-19
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS (K904752)Boehringer Mannheim Corp.1991-04-12
STANBIO CSF/URINE TOTAL PROTEIN TEST SET (K902204)Stanbio Laboratory1990-08-22
KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT (K896440)Kenlor Industries, Inc.1990-02-16
BIOTEL MICROALBUMINURIA (TM) (K894169)American Diagnostic Corp.1989-09-18
DIALBUMIN (K891544)Exocell, Inc.1989-06-09
BIOTROL URINE PROTEINS REAGENT (K890846)Biotrol, USA, Inc.1989-03-21
PROGENE MICROALBUMINURIA SCREEN (K882538)Progene Corp.1989-03-13
BIOTROL URINE PROTEINS REAGENT (K885053)Biotrol, USA, Inc.1989-01-30
ALBUWELL (K884146)Exocell, Inc.1989-01-23
MICRO-BUMINTEST REAGENT TABLETS (K874909)Miles Laboratories, Inc.1988-04-28
DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI (K851338)Diagnostic Products Corp.1986-04-07
HELENA BIOSTRIP P (K830977)Helena Laboratories1983-04-28
KOVA STRIP 6 (K811219)Icl Scientific1981-05-21

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Every clearance here is in the API, with alerts when new ones post.