Cleared Traditional

K843138 - CMV TEST

K843138 is an FDA 510(k) clearance for CMV TEST, manufactured by Microbiological Research Corp.. The device is a Class 2 Microbiology device with product code LIN cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K843138 · Microbiological Research Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1985
Decision
173d
Days
Class 2
Risk

K843138 is an FDA 510(k) clearance for the CMV TEST. Classified as Antisera, Conjugated Fluorescent, Cytomegalovirus (product code LIN), Class II - Special Controls.

Submitted by Microbiological Research Corp. (Bountiful, US). The FDA issued a Cleared decision on January 29, 1985 after a review of 173 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - 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 Microbiological Research Corp. devices

FDA 510(k) Submission Details - K843138

510(k) Number K843138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1984
Decision Date January 29, 1985
Days to Decision 173 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 102d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIN Device Classification - Class 2, Special Controls

Product Code LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
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 - LIN Antisera, Conjugated Fluorescent, Cytomegalovirus

All 15
Devices cleared under the same product code (LIN) and FDA review panel - the closest regulatory comparables to K843138.
CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)
K893467 · Immuno Concepts, Inc. · Jul 1989
CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893468 · Immuno Concepts, Inc. · Jul 1989
CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
K860279 · Bartels Immunodiagnostic Supplies, Inc. · May 1986
CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI
K820895 · Bartels Immunodiagnostic Supplies, Inc. · May 1982