FDA 510(k) Premarket Notification K951364: MICROSOMAL EIA TEST KIT

Submission Details & Decision

Normalized public record details for 510(k) notification K951364.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K951364

Applicant / Sponsor

Immunoprobe, Inc.

Device Name

MICROSOMAL EIA TEST KIT

Product Code

JNL

Decision Date

1995-11-20

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Immunology (IM)

Clearance Type

Traditional

Third Party Flag

Date Received

1995-03-24

Related Establishments / Registrations

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MONOBIND, INC. Registration: 2020726 View Registration
Diagnostic Automation/ Cortez Diagnostics Inc,. Registration: 2029372 View Registration
EPITOPE DIAGNOSTICS, INC. Registration: 2032839 View Registration
BECKMAN COULTER, INC. Registration: 2122870 View Registration
DRG International, Inc. Registration: 2245285 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
DRG INSTRUMENTS GMBH Registration: 3002800697 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
SENSOR HEALTH PRODUCTS, INC. Registration: 3004192065 View Registration
IMMUNOCENTRIX CORPORATION Registration: 3022178699 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 Information may be outdated or incomplete.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.