Phadezym Rast Allergen Discs
FDA 510(k) K823842 · Pharmacia, Inc.
510(k) numberK823842
Submission
- Device name
- Phadezym Rast Allergen Discs
- Applicant
- Pharmacia, Inc.
Walker, MI, US - Received
- December 21, 1982
- Decision date
- January 12, 1983
- 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 Phadezym Rast Allergen Discs cleared by the FDA?
Phadezym Rast Allergen Discs (K823842) received a 510(k) decision of Substantially Equivalent on January 12, 1983, 22 days after the submission was received.
What is the product code of K823842?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.