Submission Details
| 510(k) Number | K951208 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 17, 1995 |
| Decision Date | February 14, 1996 |
| Days to Decision | 334 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
ROTA-DAN RAPID ROTAVIRUS EIA KIT
Feb 1996
Decision
334d
Days
Class 1
Risk
About This 510(k) Submission
K951208 is an FDA 510(k) clearance for the ROTA-DAN RAPID ROTAVIRUS EIA KIT, a Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I — General Controls, product code LIQ), submitted by Eldan Technologies, Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on February 14, 1996, 334 days after receiving the submission on March 17, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.
Device Classification
| Product Code | LIQ — Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3405 |
Manufacturer
Similar Devices — LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
All 32
K990842 · Sa Scientific, Inc.
· Aug 1999
K972895 · Biomerieux Vitek, Inc.
· Oct 1997
K971585 · Meridian Diagnostics, Inc.
· Aug 1997
K964424 · Trinity Biotech, Inc.
· Aug 1997
K965092 · Biomerieux Vitek, Inc.
· May 1997
K942286 · Orion Diagnostica, Inc.
· Dec 1994