K093297 is an FDA 510(k) clearance for the EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE. This device is classified as a Acid, Lactic, Enzymatic Method (Class I - General Controls, product code KHP).
Submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on June 9, 2010, 231 days after receiving the submission on October 21, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1450.
| 510(k) Number | K093297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 2009 |
| Decision Date | June 09, 2010 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KHP - Acid, Lactic, Enzymatic Method |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1450 |