Cleared Traditional

K780524 - ULTRACHEM T-BILI 64971 GILFORD 3500

K780524 is an FDA 510(k) clearance for ULTRACHEM T-BILI 64971 GILFORD 3500, manufactured by Harleco. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K780524 · Harleco · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1978
Decision
49d
Days
Class 2
Risk

K780524 is an FDA 510(k) clearance for the ULTRACHEM T-BILI 64971 GILFORD 3500. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on May 19, 1978 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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 Harleco devices

FDA 510(k) Submission Details - K780524

510(k) Number K780524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1978
Decision Date May 19, 1978
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIG Device Classification - Class 2, Special Controls

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 Chemistry devices follow this clearance model.

Regulatory Peers - CIG Diazo Colorimetry, Bilirubin

All 215
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K780524.
GAMMA SMAC REAGENTS
K790578 · Gamma Enterprises, Inc. · May 1979
BILIRUBIN, DINGLE VALVE DPD
K781921 · Boehringer Mannheim Corp. · Jan 1979
BILIRUBIN DETERMINTAITON IN SERUM
K781610 · Fisher Scientific Co., LLC · Oct 1978
TOTAL BILIRUBIN
K771840 · Gamma Enterprises, Inc. · Oct 1977
MULTISTAT III, TOTAL BILIRUBIN TEST
K771621 · Instrumentation Laboratory CO · Sep 1977
UNIPAK TOTAL BILIRUBIN
K771089 · Harleco · Jul 1977