Cleared Traditional

K770216 - VIRAL ANTISERA, FLUORESCEIN LABELED

K770216 is an FDA 510(k) clearance for VIRAL ANTISERA, manufactured by Flow Laboratories, Inc.. The device is a Class 1 Immunology device with product code GRA cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K770216 · Flow Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1977
Decision
27d
Days
Class 1
Risk

K770216 is an FDA 510(k) clearance for the VIRAL ANTISERA, FLUORESCEIN LABELED. Classified as Antiserum, Fluorescent, Mumps Virus (product code GRA), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1977 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3380 - 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 Flow Laboratories, Inc. devices

FDA 510(k) Submission Details - K770216

510(k) Number K770216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1977
Decision Date March 01, 1977
Days to Decision 27 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
78d faster than avg
Panel avg: 105d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

GRA Device Classification - Class 1, General Controls

Product Code GRA Antiserum, Fluorescent, Mumps Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3380
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.