Cleared Traditional

GLYCOHEMOGLOBIN (K810958) - FDA 510(k) Clearance

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

K810958 · Macomb Chemical Co. · Toxicology device
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Sep 1981
Decision
161d
Days
Class 2
Risk

K810958 is an FDA 510(k) clearance for the GLYCOHEMOGLOBIN. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Macomb Chemical Co. (Walker, US). The FDA issued a Cleared decision on September 16, 1981 after a review of 161 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 864.7470 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Macomb Chemical Co. devices

Submission Details

510(k) Number K810958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1981
Decision Date September 16, 1981
Days to Decision 161 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 87d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
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 Toxicology devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 248
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