Cleared Traditional

K812732 - SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE

K812732 is the FDA 510(k) clearance for SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE by Hoffmann-La Roche, Inc.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K812732 · Hoffmann-La Roche, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1981
Decision
21d
Days
Class 1
Risk

K812732 is an FDA 510(k) clearance for the SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1981 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 Hoffmann-La Roche, Inc. devices

Submission Details

510(k) Number K812732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1981
Decision Date October 19, 1981
Days to Decision 21 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
81d faster than avg
Panel avg: 102d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 175
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K812732.
SCHAEDLER AGARS
K812797 · Isle Media and Sterile Products, Inc. · Oct 1981
MOTILITY GI MEDIUM
K812798 · Isle Media and Sterile Products, Inc. · Oct 1981
SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE
K812729 · Hoffmann-La Roche, Inc. · Oct 1981
MEDICASE SOY AGAR
K811640 · Hardy Media · Jul 1981
COLUMBIA AGAR BASE
K811641 · Hardy Media · Jul 1981
TRYPTICASE
K811651 · Acumedia Manufacturers, Inc. · Jul 1981