Submission Details
| 510(k) Number | K852554 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 17, 1985 |
| Decision Date | July 18, 1985 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
Cleared
Traditional
SRT-SYSTEM
Jul 1985
Decision
31d
Days
Class 1
Risk
About This 510(k) Submission
K852554 is an FDA 510(k) clearance for the SRT-SYSTEM, a Test, Erythrocyte Sedimentation Rate (Class I — General Controls, product code JPH), submitted by Microwave Development, Inc. (Old Greenwich, US). The FDA issued a Cleared decision on July 18, 1985, 31 days after receiving the submission on June 17, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6700.
Device Classification
| Product Code | JPH — Test, Erythrocyte Sedimentation Rate |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.6700 |
Manufacturer
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