Atlas FDA

UPRO

FDA 510(k) clearance K981295 · decided 1998-10-01

Clearance details

K-number
K981295
Device name
UPRO
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1998-04-09
Decision date
1998-10-01
Days to decision
175 days
Clearance type
Traditional
Product code
JGQ
Device class
2
Regulation number
862.1635
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Irving, TX, 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 (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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30