FDA 510(k) Premarket Notification K832257: GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC

Submission Details & Decision

Normalized public record details for 510(k) notification K832257.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K832257

Applicant / Sponsor

Gelco Diagnostics, Inc.

Device Name

GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC

Product Code

CZN

Decision Date

1983-10-28

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Immunology (IM)

Clearance Type

Traditional

Third Party Flag

Date Received

1983-06-30

Related Establishments / Registrations

HELENA LABORATORIES, CORP. Registration: 1618982 View Registration
Agilent Technologies Singapore (International) Pte Ltd. Registration: 3003423869 View Registration
Agilent Technologies Inc. Registration: 3009189893 View Registration
ATSI Logistics Center ApS Registration: 3013059683 View Registration
KENT LABORATORIES, INC. Registration: 3019906 View Registration
Agilent Technologies Denmark ApS Registration: 9610099 View Registration

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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 Information may be outdated or incomplete.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.