DSL PAP RIA -DSL#3100

Acid Phosphatase (prostatic), Tartrate Inhibited

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Pap Ria -dsl#3100.

Pre-market Notification Details

Device IDK844679
510k NumberK844679
Device Name:DSL PAP RIA -DSL#3100
ClassificationAcid Phosphatase (prostatic), Tartrate Inhibited
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactGopal Savjani
CorrespondentGopal Savjani
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
Product CodeJFH  
CFR Regulation Number862.1020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-11-30
Decision Date1985-04-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.