Ige Fastscreen S6 (F1, F2, F4, F13, F14)
FDA 510(k) K885065 · 3M Company
510(k) numberK885065
Submission
- Device name
- Ige Fastscreen S6 (F1, F2, F4, F13, F14)
- Applicant
- 3M Company
Santa Clara, CA, US - Received
- December 6, 1988
- Decision date
- January 4, 1989
- 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 Ige Fastscreen S6 (F1, F2, F4, F13, F14) cleared by the FDA?
Ige Fastscreen S6 (F1, F2, F4, F13, F14) (K885065) received a 510(k) decision of Substantially Equivalent on January 4, 1989, 29 days after the submission was received.
What is the product code of K885065?
The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.