Submission Details
| 510(k) Number | K944999 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 13, 1994 |
| Decision Date | June 06, 1995 |
| Days to Decision | 236 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3
Jun 1995
Decision
236d
Days
Class 1
Risk
About This 510(k) Submission
K944999 is an FDA 510(k) clearance for the SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3, 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 June 6, 1995, 236 days after receiving the submission on October 13, 1994. 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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