Atlas FDA

PROPOXYPHENE

FDA 510(k) clearance K013100 · decided 2002-03-20

Clearance details

K-number
K013100
Device name
PROPOXYPHENE
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2001-09-17
Decision date
2002-03-20
Days to decision
184 days
Clearance type
Traditional
Product code
JXN
Device class
2
Regulation number
862.3700
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Irving, TX, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Abbott Laboratories

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
Wondfo Propoxyphene Urine Test (K152495)Guangzhou Wondfo Biotech Co., Ltd.2015-11-23
FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD (K122752)Branan Medical Corp.2013-01-30
PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL (K111363)Medica Corp.2011-12-06
ONLINE DAT PROPOXYPHENE PLUS (K043303)Roche Diagnostics Corp.2005-03-11
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE (K040445)ACON Laboratories, Inc.2004-05-19
'RAPID ONE' - PROPOXYPHENE TEST (K030835)American Bio Medica Corp.2003-05-22
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) (K023795)Lin-Zhi International, Inc.2003-01-21
INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST (K022915)Alfa Scientific Designs, Inc.2002-11-29
VERDICT-II PROPOXYPHENE (K020787)Medtox Diagnostics, Inc.2002-05-02
MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 (K011163)Syva Co., Dade Behring, Inc.2001-05-10
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (K993981)Syva Co.2000-02-01
MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (K983700)Roche Diagnostic Systems, Inc.1998-12-11

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