Submission Details
| 510(k) Number | K921658 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 07, 1992 |
| Decision Date | March 22, 1993 |
| Days to Decision | 349 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
ANTI-DSDNA ANTIBODY TEST
Mar 1993
Decision
349d
Days
Class 2
Risk
About This 510(k) Submission
K921658 is an FDA 510(k) clearance for the ANTI-DSDNA ANTIBODY TEST, a Anti-dna Antibody, Antigen And Control (Class II — Special Controls, product code LSW), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on March 22, 1993, 349 days after receiving the submission on April 7, 1992. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | LSW — Anti-dna Antibody, Antigen And Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
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