Submission Details
| 510(k) Number | K000718 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 03, 2000 |
| Decision Date | August 24, 2000 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
CHROMOSTREAK
Aug 2000
Decision
174d
Days
Class 1
Risk
About This 510(k) Submission
K000718 is an FDA 510(k) clearance for the CHROMOSTREAK, a Culture Media, Propagating Transport (Class I — General Controls, product code JSN), submitted by Novamed , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on August 24, 2000, 174 days after receiving the submission on March 3, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.
Device Classification
| Product Code | JSN — Culture Media, Propagating Transport |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.2390 |
Manufacturer
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