Submission Details
| 510(k) Number | K071346 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 14, 2007 |
| Decision Date | September 24, 2007 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
Sep 2007
Decision
133d
Days
Class 2
Risk
About This 510(k) Submission
K071346 is an FDA 510(k) clearance for the IMMULISA INTRINSIC FACTOR ANTIBODY ELISA, a Radioassay, Intrinsic Factor Blocking Antibody (Class II — Special Controls, product code LIG), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on September 24, 2007, 133 days after receiving the submission on May 14, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1810.
Device Classification
| Product Code | LIG — Radioassay, Intrinsic Factor Blocking Antibody |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1810 |
Manufacturer
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