FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

899 results for "abbott laboratories"

553–576 of 899

Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry

Cleared Apr 05, 1988

ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT

VISION(R) THYROXINE (T4)

REVISED LABELING FOR ADX COCAINE METABOLITE

REVISED LABELING FOR ADX CANNABINOIDS

REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA.

REVISED LABELING FOR ADX BARBITURATES

REVISIED LABELING FOR ADX BENZODIAZEPINES

REVISED LABELING FOR ADX PHENCYCLIDINE

REVISED LABELING FOR ADX OPIATES

ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE

K874020 · KPF

Abbott Laboratories

Gastroenterology & Urology · 119d

Cleared Jan 21, 1988

A-GENT TRIGLLYCERIDES GPO

TDXR DELTA-9-CANNABINOIDS

ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL

REVISED LABELING FOR TDX BENZODIAZEPINES

REVISED LABELING FOR TDX CANNABINOIDS

REVISED LABELING FOR TDX COCAINE METABOLITE

REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA.

REVISED LABELING FOR OPIATES

REVISED LABELING FOR TDX PHENCYCLIDINE

REVISED LABELING FOR TDX BARBITURATES

K874483 · DIS

Abbott Laboratories

Toxicology · 24d