CELLULOSE ACETATE-CITRATE AGAR HEMOGLO

FDA 510(k) Premarket Notification · Submission K813395 · Applicant: Helena Laboratories

Public Record 510(k) Submission Decision Date: 1981-12-31 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K813395.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K813395

Applicant / Sponsor

Helena Laboratories

Device Name

CELLULOSE ACETATE-CITRATE AGAR HEMOGLO

Product Code

JBD

Decision Date

1981-12-31

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Hematology (HE)

Clearance Type

Traditional

Third Party Flag

Date Received

1981-12-04

Related Establishments / Registrations

HELENA LABORATORIES, CORP. Registration: 1618982 View Registration
SEBIA Registration: 8023024 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 Information may be outdated or incomplete.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.