Submission Details
| 510(k) Number | K032850 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 12, 2003 |
| Decision Date | March 18, 2004 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
Mar 2004
Decision
188d
Days
Class 2
Risk
About This 510(k) Submission
K032850 is an FDA 510(k) clearance for the IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG), a Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) (Class II — Special Controls, product code NBT), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on March 18, 2004, 188 days after receiving the submission on September 12, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5785.
Device Classification
| Product Code | NBT — Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5785 |
Manufacturer
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