Cleared Traditional

EMIT & METHOFREXATE ASSAY (K833634) - FDA 510(k) Clearance

K833634 · Syva Co. · Toxicology device
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Dec 1983
Decision
66d
Days
-
Risk

K833634 is an FDA 510(k) clearance for the EMIT & METHOFREXATE ASSAY. Classified as Enzyme Immunoassay, Methotrexate (product code LAO).

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1983 after a review of 66 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 K833634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1983
Decision Date December 22, 1983
Days to Decision 66 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 87d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAO Enzyme Immunoassay, Methotrexate
Device Class -

Regulatory Peers - LAO Enzyme Immunoassay, Methotrexate

All 9
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