Abbott Diagnostics

FDA Filings

This page includes the latest FDA filings for Abbott Diagnostics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMN K964185 ABBOTT DIAGNOSTICS	IMX CA 125	1997-11-04
PMN K972182 ABBOTT DIAGNOSTICS	ABBOTT STREP A CONTROLS	1997-08-13
PMN K961439 ABBOTT DIAGNOSTICS	ABBOTT CELL-DYN 4000 SYSTEM	1996-10-18
PMN K890491 ABBOTT DIAGNOSTICS	CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER	1989-04-18
PMN K881242 ABBOTT DIAGNOSTICS	CELL-DYN RAPID-LYSE AND HEMOGLOBLIN	1988-04-21
PMN K881130 ABBOTT DIAGNOSTICS	CELL-DYN ISOTONIC DILUENT	1988-03-31
PMN K873348 ABBOTT DIAGNOSTICS	CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.	1987-09-09
PMN K873347 ABBOTT DIAGNOSTICS	CELL-DYN DIFF. SCREEN ISOTONIC DILUENT	1987-09-09
PMN K873408 ABBOTT DIAGNOSTICS	MODEL 690 SPECTROPHOTOMETER	1987-09-08
PMN K872761 ABBOTT DIAGNOSTICS	CELL-DYN 610 HEMATOLOGY ANALYZER	1987-08-06
PMN K870233 ABBOTT DIAGNOSTICS	CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER	1987-03-17
PMN K854368 ABBOTT DIAGNOSTICS	CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER	1986-01-01
PMN K852371 ABBOTT DIAGNOSTICS	CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY	1985-09-17
PMN K852372 ABBOTT DIAGNOSTICS	CELL-DYN BRAND HEMATOLOGY REAGENTS	1985-09-03
PMN K852373 ABBOTT DIAGNOSTICS	AD150, AUTOMATED HEMATOLOGY DILUTOR	1985-07-05
PMN K845019 ABBOTT DIAGNOSTICS	CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER	1985-03-26
PMN K842786 ABBOTT DIAGNOSTICS	DYNA-LYTE 2000	1984-09-14
PMN K842446 ABBOTT DIAGNOSTICS	DILU-MATIC 140	1984-09-06
PMN K840170 ABBOTT DIAGNOSTICS	CELL-DYN 100 WHOLE BLOOD PLATELET	1984-03-02
PMN K832643 ABBOTT DIAGNOSTICS	CELL-DYN 900 HEMATOLOGY ANALYZER	1983-09-26
PMN K832206 ABBOTT DIAGNOSTICS	SPECTROPHOTOMETER #390	1983-08-24
PMN K832038 ABBOTT DIAGNOSTICS	CELL-DYN 300 HEMATOLOGY ANALYZER	1983-07-18
PMN K831368 ABBOTT DIAGNOSTICS	CELL-DYN 400 HEMOTOLOGY ANALYZER	1983-07-18
PMN K830624 ABBOTT DIAGNOSTICS	FLUOROMETER, GENERAL USE	1983-04-05
PMN K823344 ABBOTT DIAGNOSTICS	HEMATOLOGY ANALYZER	1982-12-28
PMN K822720 ABBOTT DIAGNOSTICS	MODEL 340 SPECTROPHOTOMETER	1982-10-08
PMN K803218 ABBOTT DIAGNOSTICS	CELL DYN 800 HEMATOLOGY ANALYZER	1981-06-09
PMN K810135 ABBOTT DIAGNOSTICS	MODEL AM 721 ELECTROLYTE ANALYZER	1981-02-10

Similar & Related FDA Registered Companies

• Abbott Ireland Diagnostics Division
• Abbott Diagnostics Scarborough, Inc.
• Abbott Laboratories Diagnostics Division
• Abbott Rapid Diagnostics
• ABBOTT DIAGNOSTICS MFG., INC.
• Abbott Diagnostics Scarborough, Inc.10 Southgate Roadscarborough, ME 04074 PMA NumberP940035 Supplement NumberS017 Date Received02/08/2022 Decision Date07/12/2022 Product Code NAH  Advisory Committee Immunology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Abbott Diagnostics Technologies AS
• Abbott Ireland Diagnostics
• Abbott Rapid Diagnostics Informatics, Inc.

Related Finance Registrations

NCAGE Code	0TCW5	ABBOTT DIAGNOSTICS
NCAGE Code	67927	ABBOTT DIAGNOSTICS
CAGE Code	0TCW5	ABBOTT DIAGNOSTICS
CAGE Code	67927	ABBOTT DIAGNOSTICS

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091147078	Singapore,Singapore -> Los Angeles, California	MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL INSTRUMENTS (ARCHITECT C8 STDALN RSH, I2SR MOD ACCY KIT, ARCHITECT ARM UPGRD KIT)	35 BOX
2020082828116	Singapore,Singapore -> Los Angeles, California	MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL INSTRUMENTS (ARCHITECT RSH ASSY I2000SR ADD-ON, ARCHITECT C8 STDALN RSH, CD RUBY ANALYZER, CD RUBY,ACCESSORY KIT (ROHS))	32 BOX
2020081417735	Tokyo ,Japan -> Los Angeles, California	MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL INSTRUMENTS (ARCHITECT I2000SR INST, I2SR MOD ACCY KIT)	16 BOX
2020081417734	Tokyo ,Japan -> Los Angeles, California	MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED (ARCHITECT I2SR STDA RSH. ARCHITECT ARM UPGRD KIT)	16 BOX
2020081110496	Singapore,Singapore -> Los Angeles, California	MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL INSTRUMENTS (ARCHITECT I1000SR INTGR, I2SR MOD ACCY KIT, ARCHITECT ARM UPGRD KIT, CDSPHR ANALYZER,	32 BOX
2020072430033	Singapore,Singapore -> Los Angeles, California	MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL INSTRUMENTS (ARCHITECT I1000SR INTGR, I2SR MOD ACCY KIT, ARCHITECT ARM UPGRD KIT, CDSPHR ANALYZER,	32 BOX
202007231921	Singapore,Singapore -> Long Beach, California	MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL INSTRUMENTS (ALINITY I PROCESSING MODULE, ALINITY I ACCESSORY KIT)	18 BOX
202007231923	Singapore,Singapore -> Long Beach, California	MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL DIAGNOSTIC PRODUCTS,NOT RESTRICTED MEDICAL INSTRUMENTS (ALINITY I PROCESSING MODULE, ALINITY I ACCESSORY KIT)	18 BOX