FDA 510(k) Premarket Notification K770210: ANALYTIX AUTO SAMPLE PREP. STA. 1600

Submission Details & Decision

Normalized public record details for 510(k) notification K770210.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K770210

Applicant / Sponsor

G.D. Searle and Co.

Device Name

ANALYTIX AUTO SAMPLE PREP. STA. 1600

Product Code

JQW

Decision Date

1977-02-14

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1977-01-31

Related Establishments / Registrations

DYNEX TECHNOLOGIES, INC. Registration: 1117676 View Registration
BECTON, DICKINSON & CO. Registration: 1119779 View Registration
QIAGEN Registration: 1122376 View Registration
Agilent Technologies, Inc. Registration: 1217454 View Registration
HELENA LABORATORIES, CORP. Registration: 1618982 View Registration
HELENA LABORATORIES, CORP. Registration: 1644474 View Registration
TECO DIAGNOSTICS Registration: 1832216 View Registration
Caplugs, Inc. Registration: 2016673 View Registration
ONE LAMBDA, INC. Registration: 2024375 View Registration
Hologic, Inc. Registration: 2024800 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
Diagnostic Automation/ Cortez Diagnostics Inc,. Registration: 2029372 View Registration
ROCHE MOLECULAR SYSTEMS, INC. Registration: 2243471 View Registration
GLOBE SCIENTIFIC, LLC Registration: 2244900 View Registration
Alltrista Plastics LLC Registration: 2531335 View Registration
Bio-Rad Laboratories, Inc. Registration: 2915274 View Registration
HAMILTON CO. Registration: 2915796 View Registration
Agilent Technologies, Inc Registration: 2916205 View Registration
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG Registration: 3003268355 View Registration
TECAN SCHWEIZ AG Registration: 3003402518 View Registration
Tecan Trading AG Registration: 3003559191 View Registration
Apacor Limited Registration: 3003703247 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
AESKU.DIAGNOSTICS GmbH&Co.KG Registration: 3003825930 View Registration
ROCHE MOLECULAR SYSTEMS, INC. Registration: 3004141078 View Registration
LGM INTERNATIONAL INC. Registration: 3004421347 View Registration
PHADIA US INC. Registration: 3004973408 View Registration
ABBOTT MOLECULAR, INC. Registration: 3005248192 View Registration
D&K Engineering, Inc. Registration: 3005268307 View Registration
LABSYSTEMS DIAGNOSTICS Registration: 3005342322 View Registration
Bio-Rad Laboratories (Singapore) Pte. Ltd. Registration: 3006421415 View Registration
EVEREX SRL Registration: 3007082904 View Registration
EUROIMMUN US INC. Registration: 3007118747 View Registration
EUROIMMUN Medizinische Labordiagnostika AG Registration: 3007361513 View Registration
Exact Sciences Corporation- Innovation Campus Registration: 3008256118 View Registration
CELLSOLUTIONS LLC Registration: 3009034535 View Registration
Copan WASP Registration: 3009288740 View Registration
ACCUMAX LAB DEVICES PVT LTD Registration: 3009407607 View Registration
Roche Diagnostics Santa Clara Registration: 3009731198 View Registration
Integra Biotechnical, SA de CV Registration: 3009746061 View Registration
Vela Operations Singapore Pte Ltd Registration: 3009875001 View Registration
AZER SCIENTIFIC, INC. Registration: 3009963993 View Registration
Revvity Health Sciences, Inc. Registration: 3009981484 View Registration
Yantai Addcare Bio-Tech Co., Ltd. Registration: 3010031137 View Registration
KOVA INTERNATIONAL INC Registration: 3010152370 View Registration
Tecan Software Competence Center GmbH Registration: 3010160459 View Registration
LABOTEK GROUP CORP Registration: 3010194621 View Registration
ZOLLNER ELECTRONICS GMBH Registration: 3010594620 View Registration
BAEBIES INC. Registration: 3011240982 View Registration
ONE LAMBDA, INC Registration: 3013058950 View Registration
Exact Sciences Corporation- Legacy Campus Registration: 3013841562 View Registration
JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD. Registration: 3013894805 View Registration
BIOBASE BIODUSTRY(SHANDONG)CO., LTD Registration: 3014325803 View Registration
IMMCO DIAGNOSTICS, INC. Registration: 3015376545 View Registration
Exact Sciences Corporation- Discovery Campus Registration: 3015728010 View Registration
BRAIN NAVI BIOTECHNOLOGY CO., LTD. Registration: 3015797559 View Registration
LABTURBO BIOTECH CORPORATION Registration: 3016068451 View Registration
LABTURBO BIOTECH, LLC Registration: 3016611336 View Registration
BIOTEKE CORPORATION (WUXI) CO., LTD Registration: 3016837106 View Registration
ZHEJIANG BIOREAR BIOTECHNOLOGY CO.LTD Registration: 3017955445 View Registration
Dynamic Devices Registration: 3019512297 View Registration
VISIA LAB SRL Registration: 3026753391 View Registration
Becton, Dickinson and Company, BD Biosciences Registration: 3027394506 View Registration
D&K Engineering Services Sdn. Bhd. Registration: 3038193079 View Registration
BIOMERIEUX SA Registration: 8020790 View Registration
HTZ Ltd Registration: 8021864 View Registration
HAMILTON BONADUZ AG Registration: 8030996 View Registration
STRATEC SE Registration: 8043379 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.