The following data is part of a premarket notification filed by Awareness Technology, Inc. with the FDA for Project 300 Microassay Bp-12, Eia Minilab.
| Device ID | K873451 |
| 510k Number | K873451 |
| Device Name: | PROJECT 300 MICROASSAY BP-12, EIA MINILAB |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | AWARENESS TECHNOLOGY, INC. P.O. DRAWER 1679 3481 SW PALM CITY SCHOOL ROAD Palm City, FL 34990 |
| Contact | Mary Freeman |
| Correspondent | Mary Freeman AWARENESS TECHNOLOGY, INC. P.O. DRAWER 1679 3481 SW PALM CITY SCHOOL ROAD 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 | 1987-08-27 |
| Decision Date | 1987-11-04 |