The following data is part of a premarket notification filed by Awareness Technology, Inc. with the FDA for Redi-check Photmeter Q.a..
Device ID | K923598 |
510k Number | K923598 |
Device Name: | REDI-CHECK PHOTMETER Q.A. |
Classification | Coulometric, Chloride |
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 | JFS |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-20 |
Decision Date | 1992-10-14 |