The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Quantimetrix C-clear(tm).
Device ID | K931523 |
510k Number | K931523 |
Device Name: | QUANTIMETRIX C-CLEAR(TM) |
Classification | Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric) |
Applicant | QUANTIMETRIX CORP. 4955 WEST 145 ST. Hawthorne, CA 90250 -6703 |
Contact | Himawan Sutisna |
Correspondent | Himawan Sutisna QUANTIMETRIX CORP. 4955 WEST 145 ST. Hawthorne, CA 90250 -6703 |
Product Code | JMA |
CFR Regulation Number | 862.1095 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-26 |
Decision Date | 1993-06-25 |