The following data is part of a premarket notification filed by Hf Scientific, Inc. with the FDA for Rinse & Reference Solution/buffer/low & High Stan..
Device ID | K882801 |
510k Number | K882801 |
Device Name: | RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN. |
Classification | Electrode, Ion Specific, Sodium |
Applicant | HF SCIENTIFIC, INC. 3052 METRO PARKWAY SE Ft. Myers, FL 33916 |
Contact | Barbara H Sneade |
Correspondent | Barbara H Sneade HF SCIENTIFIC, INC. 3052 METRO PARKWAY SE Ft. Myers, FL 33916 |
Product Code | JGS |
CFR Regulation Number | 862.1665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-07 |
Decision Date | 1988-08-29 |