Submission Details
| 510(k) Number | K121237 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 24, 2012 |
| Decision Date | May 18, 2012 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE
May 2012
Decision
24d
Days
Class 1
Risk
About This 510(k) Submission
K121237 is an FDA 510(k) clearance for the BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Cliniqa Corporation (San Marcos, US). The FDA issued a Cleared decision on May 18, 2012, 24 days after receiving the submission on April 24, 2012. 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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