LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA— 510(k) K882340

Name: FDA 510(k) clearance K882340
Creator: U.S. Food and Drug Administration
Published: 1988-08-08

Substantially Equivalent

Serono Diagnostics, Inc.

FDA 510(k) clearance K882340 for LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA, Substantially Equivalent on 1988-08-08. Applicant: Serono Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1988-06-07
Decision date: 1988-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

Download summary PDF View on FDA.gov ↗

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