Cleared Traditional

K981208 - TFR

K981208 is an FDA 510(k) clearance for TFR, manufactured by Ramco Laboratories, Inc.. The device is a Class 2 Immunology device with product code JNM cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K981208 · Ramco Laboratories, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
202d
Days
Class 2
Risk

K981208 is an FDA 510(k) clearance for the TFR. Classified as Immunochemical, Transferrin (product code JNM), Class II - Special Controls.

Submitted by Ramco Laboratories, Inc. (Houston, US). The FDA issued a Cleared decision on October 21, 1998 after a review of 202 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5880 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ramco Laboratories, Inc. devices

FDA 510(k) Submission Details - K981208

510(k) Number K981208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1998
Decision Date October 21, 1998
Days to Decision 202 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 105d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JNM Device Classification - Class 2, Special Controls

Product Code JNM Immunochemical, Transferrin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5880
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 Immunology devices follow this clearance model.