Cleared Traditional

K771909 - DUAL WAVELENGTH PHOTOMETER

K771909 is an FDA 510(k) clearance for DUAL WAVELENGTH PHOTOMETER, manufactured by Abbott Laboratories. The device is a Class 1 Immunology device with product code JJQ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K771909 · Abbott Laboratories · Immunology device
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Dec 1977
Decision
70d
Days
Class 1
Risk

K771909 is an FDA 510(k) clearance for the DUAL WAVELENGTH PHOTOMETER, 1177. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 20, 1977 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.2300 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K771909

510(k) Number K771909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1977
Decision Date December 20, 1977
Days to Decision 70 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
34d faster than avg
Panel avg: 104d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

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 145
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K771909.
UNISTAT BILIRUBINOMETER
K781241 · American Optical Corp. · Aug 1978
FISHER SPECTROPHOTOMETER
K780902 · Bausch & Lomb, Inc. · Jun 1978
CLINICAL ANALYZER SYSTEM
K780903 · Bausch & Lomb, Inc. · Jun 1978
SPECTROPHOTOMETER ANALYSIS SYS.
K771807 · Varian Assoc., Inc. · Nov 1977
SPECTROPHOTOMETER CARY 219
K772022 · Varian Assoc., Inc. · Nov 1977
CHEMCODE/CHEMTEK SYSTEM
K771496 · Boehringer Mannheim Corp. · Oct 1977