Submission Details
| 510(k) Number | K980173 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 20, 1998 |
| Decision Date | March 18, 1998 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
Mar 1998
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K980173 is an FDA 510(k) clearance for the ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Beckman Instruments, Inc. (Chaska, US). The FDA issued a Cleared decision on March 18, 1998, 57 days after receiving the submission on January 20, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.
Device Classification
| Product Code | JHI — Visual, Pregnancy Hcg, Prescription Use |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1155 |
Manufacturer
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