FDA 510(k) Premarket Notification K834595: PARAGON ACID HEMOGLOBIN REAGENT KIT

Submission Details & Decision

Normalized public record details for 510(k) notification K834595.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K834595

Applicant / Sponsor

Beckman Instruments, Inc.

Device Name

PARAGON ACID HEMOGLOBIN REAGENT KIT

Product Code

GKA

Decision Date

1984-05-07

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Hematology (HE)

Clearance Type

Traditional

Third Party Flag

Date Received

1983-12-30

Related Establishments / Registrations

OEM SYSTEMS CO. LTD. Registration: 1000487132 View Registration
HELENA LABORATORIES, CORP. Registration: 1618982 View Registration
Trinity Biotech (Primus Corporation dba Trinity Biotech) Registration: 1931251 View Registration
Bio-Rad Laboratories, Inc. Registration: 2915274 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
ACRO BIOTECH Inc. Registration: 3005360469 View Registration
Trinity Biotech do Brasil Registration: 3032069621 View Registration
SEBIA Registration: 8023024 View Registration
WALLAC OY Registration: 8043909 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.