Submission Details
| 510(k) Number | K970778 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 04, 1997 |
| Decision Date | April 17, 1997 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4
Apr 1997
Decision
44d
Days
Class 1
Risk
About This 510(k) Submission
K970778 is an FDA 510(k) clearance for the LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on April 17, 1997, 44 days after receiving the submission on March 4, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.
Device Classification
| Product Code | JJX — Single (specified) Analyte Controls (assayed And Unassayed) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1660 |
Manufacturer
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