Cleared Traditional

K853335 - BLOOD AGAR W/AMPICILLIN, BAP W/AMPICILLIN

K853335 is an FDA 510(k) clearance for BLOOD AGAR W/AMPICILLIN, manufactured by Hardy Media. The device is a Class 1 Microbiology device with product code JSJ cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K853335 · Hardy Media · Microbiology device
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Aug 1985
Decision
10d
Days
Class 1
Risk

K853335 is an FDA 510(k) clearance for the BLOOD AGAR W/AMPICILLIN, BAP W/AMPICILLIN. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Hardy Media (Santa Barbara, US). The FDA issued a Cleared decision on August 19, 1985 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Hardy Media devices

FDA 510(k) Submission Details - K853335

510(k) Number K853335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1985
Decision Date August 19, 1985
Days to Decision 10 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
92d faster than avg
Panel avg: 102d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

JSJ Device Classification - Class 1, General Controls

Product Code JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSJ Culture Media, Selective And Non-differential

All 271
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K853335.
APL PHENYLETHYL ALCOHOL AGAR(WITH 5% SHEEP BLOOD)
K853227 · Apl Medical Supplies · Aug 1985
APL MYCOBIOTIC AGAR
K853230 · Apl Medical Supplies · Aug 1985
APL SABOURAUD DEXTROSE AGAR
K853231 · Apl Medical Supplies · Aug 1985
PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD
K851591 · Preferred Micro-Media · May 1985
SABOURAUD DEXTROSE AGAR
K851592 · Preferred Micro-Media · May 1985
SELECTIVE STREPTOCOCCUS AGAR
K851593 · Preferred Micro-Media · May 1985