The following data is part of a premarket notification filed by Awareness Technology, Inc. with the FDA for Smart Alex Compact Clinical Analyzer(cca)(filter P.
| Device ID | K850995 |
| 510k Number | K850995 |
| Device Name: | SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | AWARENESS TECHNOLOGY, INC. 3481 SW PALM CITY SCH. RD. P.O. BOX 1679 Palm City, FL 34990 |
| Contact | Mary Freeman |
| Correspondent | Mary Freeman AWARENESS TECHNOLOGY, INC. 3481 SW PALM CITY SCH. RD. P.O. BOX 1679 Palm City, FL 34990 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-11 |
| Decision Date | 1985-05-10 |