The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Bio-stat Iii Plate Washer.
Device ID | K844552 |
510k Number | K844552 |
Device Name: | BIO-STAT III PLATE WASHER |
Classification | Device, Microtiter Diluting/dispensing |
Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
Contact | Patricia B Shader |
Correspondent | Patricia B Shader WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
Product Code | JTC |
CFR Regulation Number | 866.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-21 |
Decision Date | 1985-01-30 |