The following data is part of a premarket notification filed by Shaban Mfg. Co. with the FDA for Chloride Standard.
Device ID | K844235 |
510k Number | K844235 |
Device Name: | CHLORIDE STANDARD |
Classification | Calibrator, Primary |
Applicant | SHABAN MFG. CO. 3052 METRO PKWY. Fort Myers, FL 33901 |
Contact | Barbara H Sneade |
Correspondent | Barbara H Sneade SHABAN MFG. CO. 3052 METRO PKWY. Fort Myers, FL 33901 |
Product Code | JIS |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-01 |
Decision Date | 1984-11-20 |