The following data is part of a premarket notification filed by Quantitative Technologies, Inc. with the FDA for Ria-quick.
Device ID | K881194 |
510k Number | K881194 |
Device Name: | RIA-QUICK |
Classification | Calculator/data Processing Module, For Clinical Use |
Applicant | QUANTITATIVE TECHNOLOGIES, INC. 40 UPTON RD. P.O. BOX 1245 Westboro, MA 01581 |
Contact | M Broverman |
Correspondent | M Broverman QUANTITATIVE TECHNOLOGIES, INC. 40 UPTON RD. P.O. BOX 1245 Westboro, MA 01581 |
Product Code | JQP |
CFR Regulation Number | 862.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-21 |
Decision Date | 1988-06-01 |