Cleared Traditional

K953395 - SYNERMED CALCIUM REAGENT KIT

K953395 is the FDA 510(k) clearance for SYNERMED CALCIUM REAGENT KIT by Synermed, Inc.. It is a Class 2 Chemistry device (product code CJY) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K953395 · Synermed, Inc. · Chemistry device
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Aug 1995
Decision
44d
Days
Class 2
Risk

K953395 is an FDA 510(k) clearance for the SYNERMED CALCIUM REAGENT KIT. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on August 31, 1995 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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: 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 Synermed, Inc. devices

Submission Details

510(k) Number K953395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1995
Decision Date August 31, 1995
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 88d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJY Azo Dye, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - CJY Azo Dye, Calcium

All 33
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K953395.
RANDOX CALCIUM
K974607 · Randox Laboratories, Ltd. · Feb 1998
SIGMA DIAGNOSTICS CALICIUM REAGENT
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EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE
K961226 · Johnson & Johnson Clinical Diagnostics, Inc. · May 1996
DMA CALCIUM PLUS PROCEDURE
K944255 · Data Medical Associates, Inc. · Dec 1994
HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808
K941764 · Hi Chem, Inc. · May 1994
SIGMA CALCIUM REAGENT
K933678 · Sigma Chemical Co. · Mar 1994