Cleared Traditional

K875207 - ALBUMIN CAT. # 201-03

K875207 is an FDA 510(k) clearance for ALBUMIN CAT. # 201-03, manufactured by Diagnostic Chemicals, Ltd. (Usa). The device is a Class 2 Chemistry device with product code CIX cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K875207 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Apr 1988
Decision
122d
Days
Class 2
Risk

K875207 is an FDA 510(k) clearance for the ALBUMIN CAT. # 201-03. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Monroe, US). The FDA issued a Cleared decision on April 18, 1988 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Chemicals, Ltd. (Usa) devices

FDA 510(k) Submission Details - K875207

510(k) Number K875207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1987
Decision Date April 18, 1988
Days to Decision 122 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 88d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIX Device Classification - Class 2, Special Controls

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 Chemistry devices follow this clearance model.

Regulatory Peers - CIX Bromcresol Green Dye-binding, Albumin

All 106
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K875207.
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K880313 · Wako Chemicals USA, Inc. · Mar 1988
ALBUMIN, BROMCRESOL GREEN DYE-BINDING
K875070 · Tech-Co, Inc. · Jan 1988