Cleared Traditional

ABUSCREEN RIA FOR PHENCYCLIDINE (K790655) - FDA 510(k) Clearance

K790655 · Hoffmann-La Roche, Inc. · Toxicology device

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Jun 1979

Decision

71d

Days

Risk

K790655 is an FDA 510(k) clearance for the ABUSCREEN RIA FOR PHENCYCLIDINE. Classified as Radioimmunoassay, Phencyclidine (product code LCL).

Submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1979 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel. 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 Hoffmann-La Roche, Inc. devices

Submission Details

510(k) Number	K790655 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 05, 1979
Decision Date	June 15, 1979
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

16d faster than avg

Panel avg: 87d · This submission: 71d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	LCL Radioimmunoassay, Phencyclidine
Device Class	-

Regulatory Peers - LCL Radioimmunoassay, Phencyclidine

All 10

Devices cleared under the same product code (LCL) and FDA review panel - the closest regulatory comparables to K790655.

ABUSCREEN FP FOR PHENCYCLIDINE

K890882 · Roche Diagnostic Systems, Inc. · Mar 1989

EMIT HVA PHENCYCLIDINE ASSAY

K882179 · Syva Co. · Jul 1988

REVISED LABELING FOR ADX PHENCYCLIDINE

K880011 · Abbott Laboratories · Feb 1988

REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS

K874626 · Syva Co. · Jan 1988

REVISED LABELING FOR TDX PHENCYCLIDINE

K874484 · Abbott Laboratories · Nov 1987

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K790655

Hoffmann-La Roche, Inc.

Mchenry, IL · US

Regulatory profile

49 submissions 49 cleared

100% clearance rate · Active in Toxicology

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Sourced from FDA 510(k) public files . Updated monthly.

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