Submission Details
| 510(k) Number | K974428 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 24, 1997 |
| Decision Date | July 30, 1998 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
DIPSTREAK
Jul 1998
Decision
248d
Days
Class 1
Risk
About This 510(k) Submission
K974428 is an FDA 510(k) clearance for the DIPSTREAK, a Culture Media, Selective And Differential (Class I — General Controls, product code JSI), submitted by Novamed , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on July 30, 1998, 248 days after receiving the submission on November 24, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.
Device Classification
| Product Code | JSI — Culture Media, Selective And Differential |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.2360 |
Manufacturer
Similar Devices — JSI Culture Media, Selective And Differential
All 284
K070691 · Becton, Dickinson & CO
· Nov 2007
K891593 · Oxoid U.S.A., Inc.
· Jun 1989
K890199 · Orion Corp.
· Mar 1989
K882182 · Lakewood Biochemical Co., Inc.
· Jun 1988
K881555 · Acumedia Manufacturers, Inc.
· Apr 1988
K881556 · Acumedia Manufacturers, Inc.
· Apr 1988