Cleared Traditional

DSL ACTIVE PROLACTIN ELISA MODEL 10-4500

K960561 · Diagnostic Systems Laboratories, Inc. · Chemistry
Apr 1996
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K960561 is an FDA 510(k) clearance for the DSL ACTIVE PROLACTIN ELISA MODEL 10-4500, a Radioimmunoassay, Prolactin (lactogen) (Class I — General Controls, product code CFT), submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on April 26, 1996, 77 days after receiving the submission on February 9, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number K960561 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 1996
Decision Date April 26, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CFT — Radioimmunoassay, Prolactin (lactogen)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1625

Similar Devices — CFT Radioimmunoassay, Prolactin (lactogen)

All 79
PROLACTIN (PRL) HORMONE MICROPLATE ELISA
K971921 · Monobind · Jun 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
K970281 · Johnson & Johnson Clinical Diagnostics, Inc. · Feb 1997
SEALITE SCIENCES, INC. AQUALITE PROLACTIN
K970188 · Sealite Sciences, Inc. · Feb 1997
ELECSYS PROLACTIN ASSAY
K964748 · Boehringer Mannheim Corp. · Jan 1997
DSL ACTIVE PROLACTIN IRMA
K960060 · Diagnostic Systems Laboratories, Inc. · Feb 1996
ACCESS PROLACTIN ASSAY (MODIFICATION)
K954680 · Bio-Rad Laboratories, Inc. · Oct 1995