Cleared Traditional

K770597 - DASP TM ANTI-RABBIT

K770597 is the FDA 510(k) clearance for DASP TM ANTI-RABBIT by Organon, Inc.. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K770597 · Organon, Inc. · Immunology device
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Apr 1977
Decision
30d
Days
Class 2
Risk

K770597 is an FDA 510(k) clearance for the DASP TM ANTI-RABBIT. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Organon, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1977 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device 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 Organon, Inc. devices

Submission Details

510(k) Number K770597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1977
Decision Date April 28, 1977
Days to Decision 30 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 104d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEW Igg, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DEW Igg, Antigen, Antiserum, Control

All 54
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K770597.
ANTISERUM TO HUMAN IGG
K790704 · Kent Laboratories, Inc. · Apr 1979
IMMUNOGLOBULIN G NEPHEL. ASSAY
K772252 · Kallestad Laboratories, Inc. · Dec 1977
GOAT ANTISERUM IGG NEPHELOMETRIC
K770961 · Kallestad Laboratories, Inc. · Jun 1977
FLUORESCEIN CONJUGATED ANTISERUM
K770668 · Kent Laboratories, Inc. · Apr 1977
RHODAMINE-CONJUGATED ANTISERUM
K770669 · Kent Laboratories, Inc. · Apr 1977
FLUOR. CONJUGATED ANTISERUM
K770484 · Kent Laboratories, Inc. · Mar 1977