Atlas FDA

TESTPACK ACUTE HCG URINGE CONTROLS

FDA 510(k) clearance K863127 · decided 1986-09-15

Clearance details

K-number
K863127
Device name
TESTPACK ACUTE HCG URINGE CONTROLS
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1986-08-15
Decision date
1986-09-15
Days to decision
31 days
Clearance type
Traditional
Product code
JJW
Device class
1
Regulation number
862.1660
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Abbott Park, IL, 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.

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RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 (K110846)Randox Laboratories Limited2011-09-30
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL (K103387)ACON Laboratories, Inc.2011-02-02
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 (K081908)Cliniqa Corporation2009-01-16
IRISPEC,CA/CB/CC (K072640)Iris Diagnostics2007-12-21
LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X (K070848)Bio-Rad, Diagnostics Grp.2007-04-25
ADVIA CHEMISTRY MICROALBUMIN CONTROLS (K052242)Bayer Healthcare, LLC2005-10-03
RANDOX URINE CONTROLS (K043266)Randox Laboratories, Ltd.2005-02-15
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS (K042446)Bio-Rad Laboratories, Inc.2004-11-02
URICHEMTRAK LIQUID ASSAYED URINE CONTROL (K031441)Medical Analysis Systems, Inc.2003-07-01

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