Cleared Traditional

K770306 - ANALYZER

K770306 is the FDA 510(k) clearance for ANALYZER by Sclavo, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K770306 · Sclavo, Inc. · Chemistry device
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Apr 1977
Decision
48d
Days
Class 1
Risk

K770306 is an FDA 510(k) clearance for the ANALYZER, 751 KINETIC/ENDPOINT. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Sclavo, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1977 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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 Sclavo, Inc. devices

Submission Details

510(k) Number K770306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1977
Decision Date April 05, 1977
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 134
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K770306.
SPECTROPHOTOMETER CARY 219
K772022 · Varian Assoc., Inc. · Nov 1977
CHEMCODE/CHEMTEK SYSTEM
K771496 · Boehringer Mannheim Corp. · Oct 1977
SPECTROPHOTOMETER ANALYSIS SYSTEM
K771637 · Varian Assoc., Inc. · Oct 1977
SPECTROPHOTOMETERS, INFRARED MODELS X99
K770278 · The Perkin-Elmer Corp. · Mar 1977
SPECTROPHOTOMETER, MODEL 597 IR
K770288 · The Perkin-Elmer Corp. · Mar 1977
SCATTERED TRANSMISSION ACCESSORY
K760737 · The Perkin-Elmer Corp. · Nov 1976