Cleared Traditional

K864237 - CARY BLAIR TRANSPORT MEDIUM

K864237 is an FDA 510(k) clearance for CARY BLAIR TRANSPORT MEDIUM, manufactured by Mds Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K864237 · Mds Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
154d
Days
Class 1
Risk

K864237 is an FDA 510(k) clearance for the CARY BLAIR TRANSPORT MEDIUM. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Mds Laboratories, Inc. (L5j 2m4, CA). The FDA issued a Cleared decision on March 31, 1987 after a review of 154 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mds Laboratories, Inc. devices

FDA 510(k) Submission Details - K864237

510(k) Number K864237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date March 31, 1987
Days to Decision 154 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
52d slower than avg
Panel avg: 102d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

JSM Device Classification - Class 1, General Controls

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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 - JSM Culture Media, Non-propagating Transport

All 77
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K864237.
STUARTS TRANSPORT MEDIUM
K881569 · Acumedia Manufacturers, Inc. · Apr 1988
PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II
K872507 · Precision Dynamics Corp. · Jul 1987
IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
K864998 · Boots-Celltech Diagnostics, Inc. · Apr 1987
PATHFINDER(TM) SPECIMEN COLLECTION KIT
K863682 · Kallestad Laboratories, Inc. · Oct 1986
BUFFERED GLYCEROL SALINE
K863602 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
CARY-BLAIR TRANSPORT MEDIUM
K863527 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986