The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for 3m Ige Single Point Fast Test.
Device ID | K913212 |
510k Number | K913212 |
Device Name: | 3M IGE SINGLE POINT FAST TEST |
Classification | System, Test, Radioallergosorbent (rast) Immunological |
Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
Contact | Sylvia Zorich |
Correspondent | Sylvia Zorich WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
Product Code | DHB |
CFR Regulation Number | 866.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-19 |
Decision Date | 1991-11-22 |