Submission Details
| 510(k) Number | K121143 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 16, 2012 |
| Decision Date | May 18, 2012 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
May 2012
Decision
32d
Days
Class 1
Risk
About This 510(k) Submission
K121143 is an FDA 510(k) clearance for the LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3), a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Bio-Rad Laboratories (Irvine, US). The FDA issued a Cleared decision on May 18, 2012, 32 days after receiving the submission on April 16, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3280.
Device Classification
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.3280 |
Manufacturer
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