Cleared Traditional

KIT, FOLATE RADIOASSAY SC.7 (K760207) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K760207 · Amersham Corp. · Chemistry device
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Jul 1976
Decision
17d
Days
Class 2
Risk

K760207 is an FDA 510(k) clearance for the KIT, FOLATE RADIOASSAY SC.7. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Amersham Corp. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1976 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1295 - 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 Amersham Corp. devices

Submission Details

510(k) Number K760207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1976
Decision Date July 26, 1976
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGN Acid, Folic, Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1295
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 - CGN Acid, Folic, Radioimmunoassay

All 32
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K760207.
'NO-BOIL' DUALCOUNT KIT
K810001 · Diagnostic Products Corp. · Jan 1981
125 I FOLATE SOLID PHASE RADIOASSAY
K792167 · Abbott Laboratories · Nov 1979
FOLATE REAGENT KIT, ARIA-II SYSTEM
K780557 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1978
PROCEDURE, RED CELL FOLATE ASSAY
K760133 · Bio-Rad · Jul 1976