Atlas FDA

URINARY/CSF PROTEIN

FDA 510(k) clearance K913615 · decided 1991-09-13

Clearance details

K-number
K913615
Device name
URINARY/CSF PROTEIN
Applicant
Boehringer Mannheim Corp.
Decision
Substantially Equivalent
Date received
1991-08-13
Decision date
1991-09-13
Days to decision
31 days
Clearance type
Traditional
Product code
JGQ
Device class
2
Regulation number
862.1635
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ENZYMUN TEST{R} CEA (P860058/S001)Boehringer Mannheim Corp.1993-07-29
ENZYMUN-TEST{R} AFP (P860044/S003)Boehringer Mannheim Corp.1991-09-03
ENZYMUN-TEST{R} AFP (P860044/S002)Boehringer Mannheim Corp.1991-07-19
ENZYMUN-TEST{R} AFP (P860044/S001)Boehringer Mannheim Corp.1990-08-03
MICUR-MIC SYSTEMS (P820073)Boehringer Mannheim Corp.1983-06-29