The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for The Fiax 5000 Fluorometer.
Device ID | K863434 |
510k Number | K863434 |
Device Name: | THE FIAX 5000 FLUOROMETER |
Classification | Fluorometer |
Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
Contact | Patricia B Shrader |
Correspondent | Patricia B Shrader WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
Product Code | JZT |
CFR Regulation Number | 866.4520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-04 |
Decision Date | 1986-10-29 |