3M Multi-Allergen Ige Fastscreen(Tm) S8
FDA 510(k) K900244 · 3M Company
510(k) numberK900244
Submission
- Device name
- 3M Multi-Allergen Ige Fastscreen(Tm) S8
- Applicant
- 3M Company
Santa Clara, CA, US - Received
- January 17, 1990
- Decision date
- February 21, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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Questions and answers
When was 3M Multi-Allergen Ige Fastscreen(Tm) S8 cleared by the FDA?
3M Multi-Allergen Ige Fastscreen(Tm) S8 (K900244) received a 510(k) decision of Substantially Equivalent on February 21, 1990, 35 days after the submission was received.
What is the product code of K900244?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.