Cleared Traditional

K800787 - ANTIBODY TO VARICELLA-ZOSTER VIRUS

K800787 is the FDA 510(k) clearance for ANTIBODY TO VARICELLA-ZOSTER VIRUS by Electro-Nucleonics Laboratories, Inc.. It is a Class 2 Microbiology device (product code GGW) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K800787 · Electro-Nucleonics Laboratories, Inc. · Microbiology device
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Jul 1980
Decision
97d
Days
Class 2
Risk

K800787 is an FDA 510(k) clearance for the ANTIBODY TO VARICELLA-ZOSTER VIRUS. Classified as Test, Time, Partial Thromboplastin (product code GGW), Class II - Special Controls.

Submitted by Electro-Nucleonics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.7925 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Electro-Nucleonics Laboratories, Inc. devices

Submission Details

510(k) Number K800787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1980
Decision Date July 14, 1980
Days to Decision 97 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 102d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGW Test, Time, Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 Microbiology devices follow this clearance model.

Regulatory Peers - GGW Test, Time, Partial Thromboplastin

All 20
Devices cleared under the same product code (GGW) and FDA review panel - the closest regulatory comparables to K800787.
AB-TROL COAGULATION CONTROL
K802232 · Helena Laboratories · Nov 1980
HEP-TROL
K801932 · Helena Laboratories · Sep 1980
VERIFY S PROD. #34141
K800925 · General Diagnostics · Jul 1980
A-GENT QUANTICHROM THROMBIGEN I
K800725 · Abbott Laboratories · Jun 1980
LANCER COAGENT APTT KIT
K792048 · Sherwood Medical Co. · Nov 1979