Cleared Traditional

K790627 - LOMBARD-DOWELL DEOXYRILBONUCLERIC ACID

K790627 is the FDA 510(k) clearance for LOMBARD-DOWELL DEOXYRILBONUCLERIC ACID by Anaerobe Systems. It is a Class 1 Microbiology device (product code JSH) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K790627 · Anaerobe Systems · Microbiology device
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May 1979
Decision
33d
Days
Class 1
Risk

K790627 is an FDA 510(k) clearance for the LOMBARD-DOWELL DEOXYRILBONUCLERIC ACID. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Anaerobe Systems (Mchenry, US). The FDA issued a Cleared decision on May 1, 1979 after a review of 33 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 Anaerobe Systems devices

Submission Details

510(k) Number K790627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1979
Decision Date May 01, 1979
Days to Decision 33 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
69d faster than avg
Panel avg: 102d · This submission: 33d
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 K790627.
PHENYLALANINE AGAR
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MOTILITY TEST MEDIUM
K791591 · Isle Media and Sterile Products, Inc. · Sep 1979
CYSTINE TRYPTIC AGAR
K791594 · Isle Media and Sterile Products, Inc. · Sep 1979
LOMBARD-DOWELL STARCH AGAR
K790618 · Anaerobe Systems · Apr 1979
LOMBARD-DOWELL MILK AGAR
K790623 · Anaerobe Systems · Apr 1979
UREAPLASMA DIFFERENTIAL BASAL AGAR MED.
K771686 · Gibco Laboratories Life Technologies, Inc. · Oct 1977