← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS I

JSMCulture Media, Non-Propagating Transport

DEVICE CLASS
Class I
REGULATION
21 CFR 866.2390
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
ImplantLife-sustainingGMP-exemptThird-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K242976Medical Wire & Equipment Company (Bath), Ltd. · 510k2025-11-26
K250205Jinan Babio Biotechnology Co., Ltd. · 510k2025-09-22
K242576Hangzhou AllTest Biotech Co., Ltd. · 510k2025-04-04
K232565Copan Italia Spa · 510k2024-10-11

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →