Cleared Traditional

K781000 - PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS

K781000 is an FDA 510(k) clearance for PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code CEO cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K781000 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1978
Decision
172d
Days
Class 1
Risk

K781000 is an FDA 510(k) clearance for the PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 4, 1978 after a review of 172 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1580 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K781000

510(k) Number K781000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1978
Decision Date December 04, 1978
Days to Decision 172 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
84d slower than avg
Panel avg: 88d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

CEO Device Classification - Class 1, General Controls

Product Code CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1580
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 - CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus

All 80
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K781000.
INORGANIC PHOSPHORUS REAGENT
K791708 · Gilford Diagnostics · Sep 1979
SERUM, INORGANIC PHOSPHOROUS
K790021 · Fisher Scientific Co., LLC · Feb 1979
REAGENT SYSTEM, INORGANIC PHOSPHORUS
K781806 · Sigma Chemical Co. · Jan 1979
ULTRACHEM PHOSPHORUS, 64973
K772156 · Harleco · Dec 1977
PHOSPHORUS TEST KIT
K771848 · Mallinckrodt Critical Care · Oct 1977
MULTISTAT III PHOSPHOROUS TEST
K771477 · Instrumentation Laboratory CO · Sep 1977