Submission Details
| 510(k) Number | K905531 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 10, 1990 |
| Decision Date | January 25, 1991 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
Cleared
Traditional
LUPUS(LE)-LATEX TEST
Jan 1991
Decision
46d
Days
Class 1
Risk
About This 510(k) Submission
K905531 is an FDA 510(k) clearance for the LUPUS(LE)-LATEX TEST, a Antisera, Fluorescent, Chlamydia Spp. (Class I — General Controls, product code LKI), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on January 25, 1991, 46 days after receiving the submission on December 10, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.3120.
Device Classification
| Product Code | LKI — Antisera, Fluorescent, Chlamydia Spp. |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3120 |
Manufacturer
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