Cleared Traditional

K843509 - EMIT 700 PHENCYCLIDINE ASSAY

K843509 · Syva Co. · Toxicology device

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Sep 1984

Decision

21d

Days

Risk

K843509 is an FDA 510(k) clearance for the EMIT 700 PHENCYCLIDINE ASSAY. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1984 after a review of 21 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 Syva Co. devices

Submission Details

510(k) Number	K843509 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 06, 1984
Decision Date	September 27, 1984
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

66d faster than avg

Panel avg: 87d · This submission: 21d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	LCM Enzyme Immunoassay, Phencyclidine
Device Class	-

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 56

Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K843509.

LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE

K873756 · Diagnostic Products Corp. · Oct 1987

TDX PHENCYCLIDINE

K854167 · Abbott Laboratories · Nov 1985

STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS

K853548 · American Dade · Sep 1985

EMIT ST SERUM PHENCYCLIDINE ASSAY

K840199 · Syva Co. · Mar 1984

EMIT ST URINE PHENCYCLIDINE ASSAY

K840061 · Syva Co. · Mar 1984

EMIT-ST SERUM PHENCYCLIDINE ASSAY

K810601 · Syva Co. · Mar 1981

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 K843509

Syva Co.

Mchenry, IL · US

Regulatory profile

448 submissions 447 cleared

100% clearance rate · Active in Toxicology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

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

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