Cleared Traditional

K821659 - RESPIRACULT-STREP DEEP BED CULTURE PAD

K821659 is the FDA 510(k) clearance for RESPIRACULT-STREP DEEP BED CULTURE PAD by Orion Diagnostica, Inc.. It is a Class 1 Microbiology device (product code JSH) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K821659 · Orion Diagnostica, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1982
Decision
62d
Days
Class 1
Risk

K821659 is an FDA 510(k) clearance for the RESPIRACULT-STREP DEEP BED CULTURE PAD. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Orion Diagnostica, Inc. (Walker, US). The FDA issued a Cleared decision on August 5, 1982 after a review of 62 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 Orion Diagnostica, Inc. devices

Submission Details

510(k) Number K821659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1982
Decision Date August 05, 1982
Days to Decision 62 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 102d · This submission: 62d
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 102
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K821659.
H BROTH
K823091 · Granite Diagnostics, Inc. · Nov 1982
V AGAR
K822702 · Granite Diagnostics, Inc. · Sep 1982
HAEMOPHILUS ID PLATE
K822377 · Granite Diagnostics, Inc. · Aug 1982
MOTILITY TEST MEDIUM
K821595 · Hardy Media · Jul 1982
VAGAR
K821609 · Hardy Media · Jul 1982
UREA AGAR SLANT
K811597 · Micro Media Laboratories · Jun 1981