Multi-Allergen Ige Fastscreen V (T1,T3,T5,T7,T10)
FDA 510(k) K883371 · 3M Company
510(k) numberK883371
Submission
- Device name
- Multi-Allergen Ige Fastscreen V (T1,T3,T5,T7,T10)
- Applicant
- 3M Company
Santa Clara, CA, US - Received
- August 10, 1988
- Decision date
- October 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DHB – System, Test, Radioallergosorbent (Rast) Immunological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5750
- Specialty
- Immunology
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| K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen…DHB · Traditional | Phadia AB | 08/03/2022SE |
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Questions and answers
When was Multi-Allergen Ige Fastscreen V (T1,T3,T5,T7,T10) cleared by the FDA?
Multi-Allergen Ige Fastscreen V (T1,T3,T5,T7,T10) (K883371) received a 510(k) decision of Substantially Equivalent on October 27, 1988, 78 days after the submission was received.
What is the product code of K883371?
The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.