Submission Details
| 510(k) Number | K990551 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 22, 1999 |
| Decision Date | March 25, 1999 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
IGG FLEX REAGENT CARTRIDGE
Mar 1999
Decision
31d
Days
Class 2
Risk
About This 510(k) Submission
K990551 is an FDA 510(k) clearance for the IGG FLEX REAGENT CARTRIDGE, a Radioimmunoassay, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFQ), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on March 25, 1999, 31 days after receiving the submission on February 22, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.
Device Classification
| Product Code | CFQ — Radioimmunoassay, Immunoglobulins (g, A, M) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5510 |
Manufacturer
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