Cleared Traditional

K904036 - BARTELS CYTOMEGALOVIRUS IMMED. EARLY AN...

K904036 is the FDA 510(k) clearance for BARTELS CYTOMEGALOVIRUS IMMED. EARLY AN... by Baxter Healthcare Corp. It is a Class 2 Microbiology device (product code LIN) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K904036 · Baxter Healthcare Corp · Microbiology device
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Oct 1990
Decision
41d
Days
Class 2
Risk

K904036 is an FDA 510(k) clearance for the BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN. Classified as Antisera, Conjugated Fluorescent, Cytomegalovirus (product code LIN), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Bellevue, US). The FDA issued a Cleared decision on October 16, 1990 after a review of 41 days - a notably fast clearance 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: 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K904036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1990
Decision Date October 16, 1990
Days to Decision 41 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
61d faster than avg
Panel avg: 102d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (LIN) and FDA review panel - the closest regulatory comparables to K904036.
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CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY
K894002 · Baxter Healthcare Corp · Aug 1989
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