Atlas FDA

JGQ

13 FDA 510(k) clearances · Product code

50 daysmedian time to decision
134 days90th percentile
13clearances measured

FDA profile

Official device name
Turbidimetric, Total Protein
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1635
Medical specialty
Clinical Chemistry
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RecordFirmDate
HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) (K131051)Hitachi Chemical Diagnostics, Inc.2013-06-07
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 (K072638)Roche Diagnostics Corp.2007-10-19
TOTAL PROTEIN URINE/CSF GEN.3 (K071239)Roche Diagnostics2007-09-14
UPRO (K981295)Abbott Laboratories1998-10-01
UPRO (K981682)Abbott Laboratories1998-09-21
TRACE MICROPROTEIN REAGENT (K925794)Trace America, Inc.1993-03-29
URINARY/CSF PROTEIN (K913615)Boehringer Mannheim Corp.1991-09-13
PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK (K903914)Baxter Healthcare Corp1990-10-03
EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 (K901083)Em Diagnostic Systems, Inc.1990-04-16
CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 (K863478)Em Diagnostic Systems, Inc.1986-10-29
SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY (K842134)Somas Medical Industries, Inc.1984-07-06
ACA URINARY PROTEIN ANALYTICAL TEST PACK (K822231)E.I. Dupont DE Nemours & Co., Inc.1982-09-30
CSF TOTAL PROTEIN TEST SET #0340 (K780110)Stanbio Laboratory1978-03-03

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