Cleared Traditional

K881437 - CHLORIDE/TOTAL CO2 SERUM RANGE LINEARIT...

K881437 is the FDA 510(k) clearance for CHLORIDE/TOTAL CO2 SERUM RANGE LINEARIT... by Hichem Diagnostics. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K881437 · Hichem Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1988
Decision
92d
Days
Class 1
Risk

K881437 is an FDA 510(k) clearance for the CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on July 6, 1988 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Hichem Diagnostics devices

Submission Details

510(k) Number K881437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1988
Decision Date July 06, 1988
Days to Decision 92 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
4d slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 472
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K881437.
AMERLITE TOTAL THYROID CONTROL SERA LAN.4001
K882727 · Amersham Corp. · Aug 1988
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
K882542 · Bio-Rad · Jul 1988
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
K881503 · Baxter Healthcare Corp · Jul 1988
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN
K881438 · Hichem Diagnostics · Jul 1988
SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS
K881436 · Hichem Diagnostics · Jun 1988
MULTI-FUNCTION BLOOD GAS CONTROL
K880447 · Bionostics, Inc. · May 1988