STANBIO PROSTATIC ACID PHOSPHATASE TEST

FDA 510(k) Premarket Notification · Submission K800693 · Applicant: Stanbio Laboratory

Public Record 510(k) Submission Decision Date: 1980-04-16 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K800693.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K800693

Applicant / Sponsor

Stanbio Laboratory

Device Name

STANBIO PROSTATIC ACID PHOSPHATASE TEST

Product Code

CKE

Decision Date

1980-04-16

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1980-03-27

Related Establishments / Registrations

TECO DIAGNOSTICS Registration: 1832216 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
INPECO SA Registration: 3010825766 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 Information may be outdated or incomplete.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.