The following data is part of a premarket notification filed by Buffalo Medical Specialties Mfg., Inc. with the FDA for Cynox I Hemoglobinometer.
Device ID | K830569 |
510k Number | K830569 |
Device Name: | CYNOX I HEMOGLOBINOMETER |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | BUFFALO MEDICAL SPECIALTIES MFG., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-22 |
Decision Date | 1983-04-08 |