3M IGE SINGLE POINT FAST TEST— 510(k) K913212
Substantially EquivalentWhittaker Bioproducts, Inc.
FDA 510(k) clearance K913212 for 3M IGE SINGLE POINT FAST TEST, Substantially Equivalent on 1991-11-22. Applicant: Whittaker Bioproducts, Inc.. Device class: 2.
Clearance details
- Applicant
- Whittaker Bioproducts, Inc.
- Product code
- Code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walkersville, MD, US
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