Submission Details
| 510(k) Number | K981354 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 14, 1998 |
| Decision Date | May 01, 1998 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
May 1998
Decision
17d
Days
Class 2
Risk
About This 510(k) Submission
K981354 is an FDA 510(k) clearance for the ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211, a Kit, Test,alpha-fetoprotein For Testicular Cancer (Class II — Special Controls, product code LOJ), submitted by Beckman Instruments, Inc. (Chaska, US). The FDA issued a Cleared decision on May 1, 1998, 17 days after receiving the submission on April 14, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.
Device Classification
| Product Code | LOJ — Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.6010 |
Manufacturer
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