Submission Details
| 510(k) Number | K971602 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 01, 1997 |
| Decision Date | June 27, 1997 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
Jun 1997
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K971602 is an FDA 510(k) clearance for the ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on June 27, 1997, 57 days after receiving the submission on May 1, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.
Device Classification
| Product Code | DHR — System, Test, Rheumatoid Factor |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5775 |
Manufacturer
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