The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Dna Stat Test Kit.
Device ID | K843904 |
510k Number | K843904 |
Device Name: | DNA STAT TEST KIT |
Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
Applicant | WHITTAKER BIOPRODUCTS, INC. P.O. BOX 127 Walkersville , MD 21793 - |
Contact | Patricia B Shrader |
Correspondent | Patricia B Shrader WHITTAKER BIOPRODUCTS, INC. P.O. BOX 127 Walkersville , MD 21793 - |
Product Code | LJM |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-03 |
Decision Date | 1984-11-01 |