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 |