Cleared Traditional

K891999 - CHLORIDE STANDARDS ITEM #SR1041

K891999 is an FDA 510(k) clearance for CHLORIDE STANDARDS ITEM #SR1041, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K891999 · Em Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
140d
Days
Class 2
Risk

K891999 is an FDA 510(k) clearance for the CHLORIDE STANDARDS ITEM #SR1041. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K891999

510(k) Number K891999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1989
Decision Date August 15, 1989
Days to Decision 140 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
52d slower than avg
Panel avg: 88d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIT Calibrator, Secondary

All 215
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K891999.
SECONDARY CALIBRATORS
K904698 · Bionostics, Inc. · Nov 1990
COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
K895648 · Ventrex Laboratories, Inc. · Jan 1990
COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.
K895649 · Ventrex Laboratories, Inc. · Jan 1990
DOCUMENT(TM) URIC ACID LINEARITY TEST SET
K893139 · Casco Standards · Jul 1989
DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET
K884197 · Casco Standards · Dec 1988
BINAS LUTEINIZING HORMONE IRMA TEST KIT
K883306 · Binax, Inc. · Oct 1988