Cleared Traditional

K964720 - VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)

K964720 is an FDA 510(k) clearance for VITROS IMMUNODIAGNOSTICS PRODUCTS FSH R..., manufactured by Johnson & Johnson Clinical Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K964720 · Johnson & Johnson Clinical Diagnostics, Inc. · Chemistry device
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Feb 1997
Decision
71d
Days
Class 1
Risk

K964720 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATOR.... Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on February 4, 1997 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Johnson & Johnson Clinical Diagnostics, Inc. devices

FDA 510(k) Submission Details - K964720

510(k) Number K964720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1996
Decision Date February 04, 1997
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 88d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

CGJ Device Classification - Class 1, General Controls

Product Code CGJ Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 69
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K964720.
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SEALITE SCIENCES AQUALITE FSH
K970085 · Sealite Sciences, Inc. · Feb 1997
ELECSYS FSH ASSAY
K964693 · Boehringer Mannheim Corp. · Dec 1996
DSL ACTIVE FSH IRMA
K962118 · Diagnostic Systems Laboratories, Inc. · Sep 1996
AMERLITE FSH ASSAY
K952285 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995