Cleared Traditional

K800601 - HYDRAGAMMA 16

K800601 is an FDA 510(k) clearance for HYDRAGAMMA 16, manufactured by Innotron of Oregon, Inc.. The device is a Class 1 Chemistry device with product code JJJ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K800601 · Innotron of Oregon, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1980
Decision
24d
Days
Class 1
Risk

K800601 is an FDA 510(k) clearance for the HYDRAGAMMA 16. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Innotron of Oregon, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1980 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2320 - 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 Innotron of Oregon, Inc. devices

FDA 510(k) Submission Details - K800601

510(k) Number K800601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1980
Decision Date April 10, 1980
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

JJJ Device Classification - Class 1, General Controls

Product Code JJJ Counter (beta, Gamma) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2320
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 - JJJ Counter (beta, Gamma) For Clinical Use

All 32
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K800601.
LIQUID SCINTILLATION SPECTROPHOTOMETER
K810345 · Beckman Instruments, Inc. · Feb 1981
PACE-4-AUTOMATIC RIA GAMMA-COUTER
K802578 · Philips Medical Systems (Cleveland), Inc. · Dec 1980
ATOMLIGHT (LIQUID SCINTILLATION SOLUTION
K801245 · New England Nuclear · Jun 1980
NML 5000 AUTO. GAMMA SCINT. COUNTER
K800388 · Nuclear Medical Laboratories, Inc. · Mar 1980
NUCLEAR SAMPLE READER
K790905 · Abbott Laboratories · Jun 1979
SCINTILLATION, LIQUID, RACKBETA
K780341 · Lkb Instruments, Inc. · May 1978