Cleared Traditional

K844516 - STARCH HYDROLYSIS AGAR W/INDICATOR

K844516 is the FDA 510(k) clearance for STARCH HYDROLYSIS AGAR W/INDICATOR by bioMerieux, Inc.. It is a Class 1 Microbiology device (product code JSH) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K844516 · bioMerieux, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1985
Decision
47d
Days
Class 1
Risk

K844516 is an FDA 510(k) clearance for the STARCH HYDROLYSIS AGAR W/INDICATOR. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by bioMerieux, Inc. (Addison, US). The FDA issued a Cleared decision on January 7, 1985 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - the FDA microbiology 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: 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 bioMerieux, Inc. devices

Submission Details

510(k) Number K844516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1984
Decision Date January 07, 1985
Days to Decision 47 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 102d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSH Culture Media, Non-selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSH Culture Media, Non-selective And Differential

All 101
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K844516.
UREA AGAR
K844548 · bioMerieux, Inc. · Jan 1985
V AGAR
K844513 · bioMerieux, Inc. · Jan 1985
DTM AGAR
K844514 · bioMerieux, Inc. · Jan 1985
HAEMOPHILUS I.D. QUAD
K844519 · bioMerieux, Inc. · Jan 1985
KLIGER IRON AGAR
K844520 · bioMerieux, Inc. · Jan 1985
SIM MEDIUM
K844521 · bioMerieux, Inc. · Jan 1985