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 |