Cleared Traditional

K781885 - SERUM, BLOOD UREA NITIOGEN

K781885 is an FDA 510(k) clearance for SERUM, manufactured by Fisher Scientific Co., LLC. The device is a Class 2 Chemistry device with product code CDW cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K781885 · Fisher Scientific Co., LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1978
Decision
43d
Days
Class 2
Risk

K781885 is an FDA 510(k) clearance for the SERUM, BLOOD UREA NITIOGEN. Classified as Diacetyl-monoxime, Urea Nitrogen (product code CDW), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on December 20, 1978 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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 Fisher Scientific Co., LLC devices

FDA 510(k) Submission Details - K781885

510(k) Number K781885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1978
Decision Date December 20, 1978
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDW Device Classification - Class 2, Special Controls

Product Code CDW Diacetyl-monoxime, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
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 - CDW Diacetyl-monoxime, Urea Nitrogen

All 14
Devices cleared under the same product code (CDW) and FDA review panel - the closest regulatory comparables to K781885.
UREA NITROGEN REAGENT SET
K821212 · Omega Medical Electronics · Jul 1982
UREA NITROGEN REAGENT SET
K813415 · Anco Medical Reagents & Assoc. · Dec 1981
SMAC REPLACEMENT REAGENTS/OF BUN-SERUM
K800673 · Diagnostic Solutions, Inc. · May 1980
DIRECT UREA NITROGEN TEST
K780262 · Hycel, Inc. · Apr 1978
BLOOD UREA NITROGEN BUN
K771830 · Gamma Enterprises, Inc. · Oct 1977
BLOOD UREA NITROGEN (BUN) REAGENT
K771312 · Mallinckrodt Critical Care · Aug 1977